22 Research Participant jobs in the United Kingdom

Senior Technology Transfer Manager – Medical Research

Location: Victoria, London / Hybrid working model.nCompany Description

LGC Ltd ( is an international life sciences company working with customers in the government, academic, pharmaceutical, agricultural biotechnology, food, environment, security and sports sectors.nLGC’s Grant Management Group (GMG) works with UK government departments and arm’s length bodies to support medical and health research across the UK. Our activities include funding call management, contract management and Intellectual Property management. We work with senior level stakeholders in academia, the NHS, government and industry to promote improvements in medical and health care in the UK and overseas.nAs part of our expanding services to government customers, LGC is expanding its expertise in technology transfer. We are looking for individuals with experience of technology transfer, intellectual property management and commercialisation of research in the medical, health and life science sectors.nJob Description

Job Purpose

To work closely with researchers and officials to ensure effective and efficient identification, management and commercialisation of intellectual property assets.nKey Activities

Manage an assigned portfolio of complex IP and commercialisation cases to deliver high quality outcomes in agreed timelinesnRegularly attend sites in London, Edinburgh, Cambridge, Salisbury, Swindon and Harwell to provide face-to-face support to researchers (at least once per week; more frequent attendance may be required based on business needs)nManaging external Law Firms and Patent Attorneys to resolve complex IP and commercialisation casesnDeveloping business cases for IP commercialisation including, but not limited to spinout company formation or sale and licensing of technologies and IP assetsnBusiness case development and negotiation including detailed analysis of the potential market, expected revenue streams and commercialisation strategynLeading negotiations with inventors, potential licensees and investors to agree terms that ensure robust position and financial rewardnFacilitate and deliver training for MRC staff on IP and CommercialisationnManaging internal and external legal advice to review and resolve contractual and collaboration agreement issuesnWorking with patent attorneys to ensure appropriate management of IP for specific casesnSupporting other team members with complex technology transfer activitiesnSupport, as required, promotion of industrial partnerships, management of the MRC reagents portfolio and provision of entrepreneurial trainingnPerform due diligence review of applications to funding schemes for IP and commercialisation related issuesnLead support of MRC researcher applications to other funders for the IP and commercial sectionsnLine management of up to two people as requirednQualifications

Required Criteria

Degree (BSc, MSc or PhD) qualified in life sciences with an additional qualification in business or law (advantageous) or comparable experiencenSignificant experience of working in a technology transfer role to commercialise complex IP and patent portfoliosnExperience of commercialisation of intellectual property in the medical and life sciences areanSignificant experience of negotiating commercialisation licences and spin out creation with a wide range of end usersnExperience of working with industry, researchers and government to identify mutually beneficial outcomes for commercialisation of IPnAbility to communicate complex information regarding intellectual property and commercialisation to a range of audiences using appropriate style and format of messagesnDesired Criteria

Experience of a customer facing service role with a wide range of active projects at any one timenExperience of working with external legal counsel and patent agents to resolve issues and ensure effective protection of IP assetsnExperience of delivering IP related training to scientistsnExperience of reviewing research funding applications and performing due diligence checksnExperience of line managing one or two direct reportsnAdditional Information

Compensation, Benefits & Working Arrangements:nSalary: £58,000 panLocation: Victoria, London / Hybrid working modelnContract Type: Full Time, PermanentnWorking Hours: 7.5 hours per daynAnnual Leave: 25 days, plus UK public holidaysnEmployee Benefits Include

Annual bonus, subject to company performancenEnhanced Contributory Pension SchemenLife Insurance CovernBenenden Healthcare MembershipnTraining and Development OpportunitiesnSeason Ticket LoannApplication

If you are excited about the prospect of joining our team and believe you possess the relevant skills and background, we invite you to apply. Please submit your CV along with a Statement of Suitability that showcases your key skills and experiences in relation to the Essential Criteria outlined in the job description. Additionally, share your enthusiasm for working with NIHR.nNB: Closing date for applications is 5pm on the 05th September, interviews to be held remotely from 8th September.nEquality, Diversity and Inclusion

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, colour, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, colour, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

#J-18808-Ljbffrn

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Purpose**
The Clinical Trial Manager (CTM) is accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards.
Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.
**Key Responsibilities**
+ Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
+ Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
+ Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
+ Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
+ Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
+ Assessment and set up the of vendors during study start up period (locally)
+ Investigator Meeting participation and preparation, and support preparation of materials for Site Initiation Visits.
+ Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
+ Validation of study related materials (i.e. protocol, ICF, patient material) and supports the review of country and site-specific documents (e.g. ICF, patient material),Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
+ Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation as well as completing site closure activities.
+ Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
+ Coordination of database locks and query follow up. Ensures timelines are met.
+ Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
+ Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
+ Coordinate study team meetings locally and collaborates with the local study team to support the management of site relationships
+ Perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
+ Perform submission to Ethics Committees and governance offices, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams
+ Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.
Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.
**Qualifications, Experience, Competencies & Systems**
Qualifications
+ Bachelor's or master's degree required. Field of study within life sciences or equivalent
Experience
+ Minimum of 4 years' industry related experience.
+ Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiative
+ Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and formal presentations.
+ Serve as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with the opportunity to contribute at a regional or global level with this expertise.
Competencies
+ Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
+ Knowledge and understanding of clinical research processes, regulations and methodology
+ Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
+ Demonstrated organizational and planning skills and independent decision-making ability
+ Effective organizational and time management skills and ability to effectively manage multiple competing priorities
+ Interpersonal, oral and written communication skills to influence, inform or guide others
Software
+ Microsoft Suite
+ CTMS
+ eDC
+ eTMF
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident - Employer
A UK Government scheme
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :44:29.417 UTC
**Location:** Uxbridge-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

CPL Life Sciences are partnering with a well renowned CRO who are seeking an experienced Clinical Trial Manager to join their Trial Management team to focus on a number of studies across phases II-III. Their trial portfolio spans across a range of therapeutics areas, with expert training provided to enhance your expertise if required on specific studies. The successful candidate will oversee the full project lifecycle, ensure compliance with industry regulations, and serve as the primary point of contact for sponsors. You will be responsible for the successful operational delivery of set goals and timescales. Key Responsibilities: Oversee day-to-day trial operations in accordance with protocols and regulatory standards Act as the primary liaison for sponsor communication on project-specific matters Maintain expert-level knowledge of assigned protocols and therapeutic areas Provide cross-functional leadership across internal teams and departments Review and contribute to protocol development, data plans, and final reports Develop and maintain detailed project execution plans Proactively assess and manage project risk Oversee vendor activities and performance Ensure site quality and supervise Clinical Research Associates Drive timelines and deliverables while meeting project milestones Qualifications required: Bachelor’s in health/life sciences (advanced degree preferred) Experience of direct clinical trial management Phases II–III experience highly desirable Flexible on therapy area background Strong leadership, organization, and communication skills If you are open to discussing new opportunities at this time then please apply here to arrange a follow-up call to find out more. This role is based on-site in central London, with one day working from home flexibility.

CPL Life Sciences are partnering with a well renowned CRO who are seeking an experienced Clinical Trial Manager to join their Trial Management team to focus on a number of studies across phases II-III. Their trial portfolio spans across a range of therapeutics areas, with expert training provided to enhance your expertise if required on specific studies. The successful candidate will oversee the full project lifecycle, ensure compliance with industry regulations, and serve as the primary point of contact for sponsors. You will be responsible for the successful operational delivery of set goals and timescales. Key Responsibilities: Oversee day-to-day trial operations in accordance with protocols and regulatory standards Act as the primary liaison for sponsor communication on project-specific matters Maintain expert-level knowledge of assigned protocols and therapeutic areas Provide cross-functional leadership across internal teams and departments Review and contribute to protocol development, data plans, and final reports Develop and maintain detailed project execution plans Proactively assess and manage project risk Oversee vendor activities and performance Ensure site quality and supervise Clinical Research Associates Drive timelines and deliverables while meeting project milestones Qualifications required: Bachelor’s in health/life sciences (advanced degree preferred) Experience of direct clinical trial management Phases II–III experience highly desirable Flexible on therapy area background Strong leadership, organization, and communication skills If you are open to discussing new opportunities at this time then please apply here to arrange a follow-up call to find out more. This role is based on-site in central London, with one day working from home flexibility.

Clinical Trial Assistant – Medical Devices Full-time, site-based – London (£30,000 - £5,000) Please read before applying – essential requirements To be considered, you must : Already have the right to work in the UK (no sponsorship available). Be based within daily commuting distance of Swansea , or able to relocate. Have completed Good Clinical Practice (GCP) training . Have at least 1 year of experience working in a clinical research or trial-related role. Applications that do not clearly demonstrate these will not be progressed due to expected high volumes. If you’ve ever wanted hands-on clinical trial experience in a regulated, high-performance research setting, this is your chance. This growing MedTech company is a global leader in light-based beauty technology. Their CE-marked, non-invasive devices are sold in over 50 countries and backed by serious clinical rigour. Now, they’re expanding their UK clinical team and hiring two Clinical Trial Assistants to help deliver a new wave of studies from their Swansea and London sites. This isn’t a desk job. You’ll be right in the thick of clinical trial operations, from patient interaction to data management, helping to ensure every trial is delivered to the highest quality. What you’ll be doing Supporting the clinical team through all phases of study delivery (start-up to close-out) Coordinating participant schedules and managing informed consent Administering light-based investigational treatments and capturing high-quality imaging data Conducting non-invasive skin measurements and monitoring patient safety Ensuring complete, accurate and timely data entry into CRFs and trial systems Upholding GCP, ISO 14155, and internal SOPs at every step Helping maintain audit-ready documentation and managing clinical supplies What makes this different? You won’t just be observing from the sidelines – you’ll be trained and trusted to deliver study activities yourself. From clinical photography to hands-on support with device treatments, this role offers genuine exposure to regulated clinical research within a close-knit team. The company invests in its people, offers a structured onboarding programme, and creates opportunities for growth within the research function. What you’ll need At least 1 year of experience supporting clinical trials (or similar regulated health/research setting) GCP training and a good understanding of trial documentation Strong organisational skills and meticulous attention to detail Confidence in communicating with participants and managing sensitive information A team-oriented, can-do attitude and flexible approach to working hours (some evenings required) Location: On-site at either Swansea (£26,000–£28,000) Rep ts to: CTA Manager Why now? With major clinical trials underway and investment in new product development, this team is growing fast. These roles are ideal for someone looking to build a long-term clinical career in the medical device space. If you’re ready to step into a dynamic, regulated clinical environment and help bring effective, high-quality products to patients around the world, apply today.

Clinical Trial Assistant – Medical Devices Full-time, site-based – London (£30,000 - £5,000) Please read before applying – essential requirements To be considered, you must : Already have the right to work in the UK (no sponsorship available). Be based within daily commuting distance of Swansea , or able to relocate. Have completed Good Clinical Practice (GCP) training . Have at least 1 year of experience working in a clinical research or trial-related role. Applications that do not clearly demonstrate these will not be progressed due to expected high volumes. If you’ve ever wanted hands-on clinical trial experience in a regulated, high-performance research setting, this is your chance. This growing MedTech company is a global leader in light-based beauty technology. Their CE-marked, non-invasive devices are sold in over 50 countries and backed by serious clinical rigour. Now, they’re expanding their UK clinical team and hiring two Clinical Trial Assistants to help deliver a new wave of studies from their Swansea and London sites. This isn’t a desk job. You’ll be right in the thick of clinical trial operations, from patient interaction to data management, helping to ensure every trial is delivered to the highest quality. What you’ll be doing Supporting the clinical team through all phases of study delivery (start-up to close-out) Coordinating participant schedules and managing informed consent Administering light-based investigational treatments and capturing high-quality imaging data Conducting non-invasive skin measurements and monitoring patient safety Ensuring complete, accurate and timely data entry into CRFs and trial systems Upholding GCP, ISO 14155, and internal SOPs at every step Helping maintain audit-ready documentation and managing clinical supplies What makes this different? You won’t just be observing from the sidelines – you’ll be trained and trusted to deliver study activities yourself. From clinical photography to hands-on support with device treatments, this role offers genuine exposure to regulated clinical research within a close-knit team. The company invests in its people, offers a structured onboarding programme, and creates opportunities for growth within the research function. What you’ll need At least 1 year of experience supporting clinical trials (or similar regulated health/research setting) GCP training and a good understanding of trial documentation Strong organisational skills and meticulous attention to detail Confidence in communicating with participants and managing sensitive information A team-oriented, can-do attitude and flexible approach to working hours (some evenings required) Location: On-site at either Swansea (£26,000–£28,000) Rep ts to: CTA Manager Why now? With major clinical trials underway and investment in new product development, this team is growing fast. These roles are ideal for someone looking to build a long-term clinical career in the medical device space. If you’re ready to step into a dynamic, regulated clinical environment and help bring effective, high-quality products to patients around the world, apply today.

Clinical Trial Assistant – Medical Devices Full-time, site-based – Swansea (£26,000–£8,000) Please read before applying – essential requirements To be considered, you must : Already have the right to work in the UK (no sponsorship available). Be based within daily commuting distance of Swansea , or able to relocate. Have completed Good Clinical Practice (GCP) training . Have at least 1 year of experience working in a clinical research or trial-related role. Applications that do not clearly demonstrate these will not be progressed due to expected high volumes. If you’ve ever wanted hands-on clinical trial experience in a regulated, high-performance research setting, this is your chance. This growing MedTech company is a global leader in light-based beauty technology. Their CE-marked, non-invasive devices are sold in over 50 countries and backed by serious clinical rigour. Now, they’re expanding their UK clinical team and hiring two Clinical Trial Assistants to help deliver a new wave of studies from their Swansea and London sites. This isn’t a desk job. You’ll be right in the thick of clinical trial operations, from patient interaction to data management, helping to ensure every trial is delivered to the highest quality. What you’ll be doing Supporting the clinical team through all phases of study delivery (start-up to close-out) Coordinating participant schedules and managing informed consent Administering light-based investigational treatments and capturing high-quality imaging data Conducting non-invasive skin measurements and monitoring patient safety Ensuring complete, accurate and timely data entry into CRFs and trial systems Upholding GCP, ISO 14155, and internal SOPs at every step Helping maintain audit-ready documentation and managing clinical supplies What makes this different? You won’t just be observing from the sidelines – you’ll be trained and trusted to deliver study activities yourself. From clinical photography to hands-on support with device treatments, this role offers genuine exposure to regulated clinical research within a close-knit team. The company invests in its people, offers a structured onboarding programme, and creates opportunities for growth within the research function. What you’ll need At least 1 year of experience supporting clinical trials (or similar regulated health/research setting) GCP training and a good understanding of trial documentation Strong organisational skills and meticulous attention to detail Confidence in communicating with participants and managing sensitive information A team-oriented, can-do attitude and flexible approach to working hours (some evenings required) Location: On-site at either Swansea (£26,000–£28,000) Rep ts to: CTA Manager Why now? With major clinical trials underway and investment in new product development, this team is growing fast. These roles are ideal for someone looking to build a long-term clinical career in the medical device space. If you’re ready to step into a dynamic, regulated clinical environment and help bring effective, high-quality products to patients around the world, apply today.

Who are we? Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded clinical trials through our collaborative Contract Research Organisation, extensive Site Network, and pioneering Therapy Development Programme. We focus on supporting mental health and central nervous system (CNS) research, with a particular emphasis on psychedelic drug development. The Role We are seeking a skilled and motivated Clinical Pharmacist to join our research delivery team. You’ll play a key role in supporting the safe and effective management of Investigational Medicinal Products (IMPs) across early and late-phase clinical trials, contributing to ground-breaking research in mental health. This position offers an exciting opportunity to work at the forefront of CNS and psychedelic clinical research, within a highly collaborative and mission-driven environment. You will be central to the delivery of clinical trials, ensuring compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Home Office regulations. What will the role entail? Lead and support the full IMP management cycle: procurement, receipt, storage, dispensing, final checking, accountability, quarantine, disposal, and returns. Support feasibility assessments, trial start-up, amendment reviews, and site readiness for new and ongoing studies. Ensure compliance with GCP, GMP, GDP, and ICH-GCP, and maintain accurate, inspection-ready documentation. Collaborate closely with Principal Investigators, research teams, and external sponsors to ensure timely and high-quality trial delivery. Act as a pharmacy representative in Sponsor and regulatory meetings including SIVs, IMs, and audits. Support training and supervision of junior staff, and deliver clinical trial training across teams. Contribute to internal audits, quality assurance, and continuous improvement of pharmacy and research operations. Support Home Office controlled drug compliance and contribute to audit preparation and reporting. What will you need? GPhC registered pharmacist. MPharm degree (or equivalent). Research experience is desirable, but not essential. Strong interpersonal, documentation, and organisational skills. The process? An initial screening call with the recruiter followed by a two-stage process with the team via Teams. Is this the role for you? At Clerkenwell Health, our core values are Compassion , Collaboration , Innovation , and Integrity . If you're passionate about improving mental health outcomes through research and ready to lead pharmacy excellence in clinical trials - we’d love to hear from you.

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting . Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met Initiates and builds solid professional relationships with key opinion leaders and clinical site staff Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data Proactive identification and management of study related risks Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements Responsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study Perform periodic QC of the TMF Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is “inspection ready” always Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred 5 years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization Prior phase II and III experience required A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with budget forecasting and management Experience with clinical studies in oncology Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Proven proficiency in overseeing large complex studies being managed in house and by a CRO Demonstrated ability to lead teams and work in a fast-paced team environment Experienced and enjoys building relationships with KOLs and site personnel Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues Demonstrated ability to build and deliver on patient enrollment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives Demonstrated ability to comprehend complex scientific concepts and data Proficient in reviewing and assessing clinical data Possesses excellent planning, time management & coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization Excellent written and oral communication skills Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.