Team Lead Study Manager Small Molecule

HOW WE CARE FOR YOU:

At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients’ lives.

• Up to 25% Sign-On/Relocation Bonus Available
• Sponsorship Opportunity
• Competitive Pay
• Comprehensive Benefits Package
• Career Advancement Opportunities including Apprenticeship

SUMMARY

The primary role of a Study Manager Team Lead of Small Molecule is to act as a Study Manager for regulatory and non-regulatory studies. The Team Lead will have direct line management of Study Managers.  

ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people’s lives  where you are supported  by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding  field of advanced laboratory science . Your voice is heard, and with that, you have an ability to make an impact on the organization and influence  your professional growth.

STATUS:  Full Time

LOCATION:  Onsite York  

DEPARTMENT:  BioA Laboratory

SCHEDULE:  Days

ATTRIBUTES

• Minimum of BSc in Chemistry or related subject
• Minimum of 8 yrs study management experience in regulated bioanalysis
• Demonstrated ability to work independently and in a team setting
• Demonstrated ability to adjust to changing priorities and to meet deadlines
• Strong organizational skills and attention to detail

RESPONSIBILITIES

• Study Management.  Ensure studies are conducted in compliance to company SOPs, policies, protocols, study plans, analytical methods and regulatory standards. Act as departmental lead with Sponsor/Client/internal teams for Bioanalytical activities conducted on assigned studies. Oversee LC-MS/MS method development and troubleshooting. Review any protocol, study plan, report, SOP or scientific paper as required. Effectively monitors study specific budgets and operational costs, triggering and contributing to the generation of proposal amendments as required.
• Leadership.  Ensure the effective performance management of teams and individuals, providing that all members have clearly defined roles, responsibilities and objectives, and any instances of below standard performance/ behaviour are managed according to appropriate procedures. Provide Leadership to enable the effective performance of the team and individuals to ensure the monthly operational schedules are executed in line with ACM commitments and client expectations. Ensure management and the York Site Leadership Team are fully informed, in a timely and transparent manner, the conduct of the day-to-day operations towards the achievement of its established goals and any deviations from the goals or company objectives.
• Quality   Document and complete any quality documentation (Quality issue, CAPA, deviation, change control) as appropriate and within the required timeframes. Expected to take the lead in regards to procedural updates and training required in response to changes/ updates to regulatory and industry standards affecting the department

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.

Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.