Clinical Affairs Manager

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

• As the Manager of the Clinical Affairs Sub-Function, oversees the strategy implementation and operations for overseeing the direction, planning, execution, clinical trials/research and the data collection activities.
• Contributes to implementation of clinical protocols and facilitates completion of final reports.
• Recruits clinical investigators and negotiates study design and costs.
• Responsible for directing human clinical trials, for company products under development.
• Participates in adverse event reporting and safety responsibilities monitoring.
• Coordinates and provides reporting information for reports submitted to the regulatory agencies.
• Monitors adherence to protocols and determines study completion.
• Coordinates and oversees investigator initiations and group studies.
• May act as consultant/liaison with other corporations when working under licensing agreements.

• Bachelor's degree
• Minimum 8 years of relevant experience

• Master’s or PhD degree in science or a related field.
• Experience with quality management system GAP analysis and audit preparation.
• Strong clinical operations background.
• Previously work in roles that require understanding of digital consumer behavior.
• Software life cycle experience.
• Experience with CAPA.

Abbott