Site Feasibility Lead - Europe - Iqvia Biotech

Full Job Description

BASIC FUNCTIONS:
Responsible for following the processes associated with the collection of Confidential Disclosure Agreements (CDA) and Feasibility Questionnaires (FQ). Perform Site Feasibility Project Team Management activities, coordinate the efforts of Site Feasibility Team Members and maintain clear client and internal team communication, process documentation, in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A Site Feasibility Lead may be assigned to one or more projects and works independently on a project with minimal to no supervision.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Organizes efforts of team members assigned to a designated project.
• Participates in financial and/or resource forecasting, as applicable. 
• Serves as IQVIA Biotech representative in interactions with the sponsor.
• Liaise with Clinical Monitoring, Study Start Up, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• Leads Site Feasibility activities and updates during weekly client teleconferences and internal team meetings.
• Serves as a team trainer and mentor as new projects are awarded.
• Manages quality and regulatory compliance among investigational sites during Site Feasibility.
• Manages study timelines. Documents study challenges and communicates them to Project Manager and SSU Lead/Management. 
• Creates/Coordinates the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
• Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
• Identifies out of scope activities to Site Feasibility Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
• Creates and disseminate Confidential Disclosure Agreements (CDA)/Questionnaires to sites and follows up accordingly to ascertain interest and to meet study timelines.
• May review CDAs on behalf of sponsor according to country and sponsor specific requirements, seeking legal/management review when required.
• Manages/Maintains up to date and accurate tracking on the Site Feasibility status for each site in applicable system(s) for the study. 
• Interim line management responsibilities as required.
• Responsible for transitioning sites from Site Feasibility to SSU representative.
• Assists in development of training and leads in training and development of junior staff.
• Experience of mentoring SSU staff in above activities.
• Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:
• Demonstrated ability in the leadership of a team of individuals in the site feasibility process.
• Strong knowledge of Regulatory and Central/Local ethic submission processes for assigned countries.
• Knowledge of clinical research process related to study start-up and medical terminology.
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple competing priorities within various clinical trials.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry SSU staff.
• Ability to oversee start-up activities in multiple countries, functions, and team members.
• Current country Regulatory Intelligence knowledge.
• Excellent verbal and written communication skills required for assigned countries.
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Working knowledge of Word, Excel is required. 
• Ability to travel periodically if needed 

MINIMUM RECRUITMENT STANDARDS:
• Bachelor’s degree (or equivalent) in science-related field preferred and
• 5-7 years relevant experience that includes 4 years of site feasibility experience and
• 1 year of demonstrated leadership experience
• Equivalent combination of education, training and experience

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .