Work with AgeneBio

We are always looking for motivated, passionate researchers and management to join our team of world-class scientists devoted to developing innovative, cutting edge therapeutics for patients with neurological and psychiatric diseases.

Clinical Project Manager

Contact Michela Gallagher (michela.gallagher@agenebio.com)

Job Responsibilities:

• Participates in the planning, implementation, and management of Phase I-III clinical trials, in collaboration with Contract Research Organization (CRO) partners.
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements.
• Actively involved in the execution of a clinical trial(s) from protocol design to the final clinical study report. Contributes to the development of clinical protocols and clinical study reports.
• Prepares and/or coordinates review and distribution of relevant documents including but not limited to: informed consent forms, case report forms, laboratory/monitoring plans, monitoring reports.
• Participates in the implementation of the operational plans for each [assigned] clinical project. Works closely with external and internal team members to ensure smooth operation and compliance with applicable regulations and FDA/EU/ICH guidelines.
• Maintains and reviews study timelines. Contributes to development of study budget(s).
• Responsible for tracking study milestones to ensure accurate tracking and reporting of study metrics and timelines.
• Ensures the ongoing compilation and reconciliation of the Trial Master File so that clinical trial(s) is “audit ready” at all times. Ensures that any audit observations are addressed appropriately and in a timely manner.
• Complies with all applicable policies regarding health, safety, and environmental policies.
• Assist with creation relevant company SOPs and process documents, as needed.
• Assist with the development and review of regulatory submissions.
• Provide AgeneBio Director of Clinical Operations and VP of R&D with regular updates on progress and operational issues related to ongoing clinical trials.

Job Requirements:

• BS in life sciences or related area and at least 4 years of clinical trial/clinical operations experience with at least 2 years of experience in clinical project management in a biopharmaceutical organization; or equivalent. Previous clinical monitoring and neuroscience experience desired.
• Working knowledge of FDA/ICH and EU clinical regulatory requirements and guidelines.
• Applies best practices to the clinical trial process; working knowledge of IND safety and other regulatory reporting.
• Strong organizational and time management skills; detailed oriented.
• Solid problem solving and analytical skills; identifies issues and problems and suggests solutions.
• Demonstrated communication skills, including presentation and writing skills.
• Demonstrated positive interpersonal skills; ability to actively maintain good professional relationships.
• Displays strong leadership skills.