Associate Project Manager II

Clinical Trial Manager

Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between the Sponsor, the Investigator and the research team. Ensures client requirements and specifications are communicated to the research teams and any issues / questions raised by the research team or investigators are communicated back to the client for resolution.

Essential Functions and Other Job Information :

• Serves as a primary point of contact for sponsors and the business unit for clinical site related aspects of the study.
• Collaborates with internal departments to ensure deliverables are met as defined within the contract and study timeline.
• Manages all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction, and data collection.
• Manages IRB submissions including creation of study specific informed consent forms, SAE notifications, and maintenance of the regulatory file and documents.
• Collects feedback from various departments to create a risk register for each study, and maintains and updates the register throughout the study; works with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct.
• Works closely with the finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs, and contract.
• Provides vendor oversight when services are contracted.

Qualifications : Education and Experience : Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities :

Management Role : No management responsibility