Apsida are currently partnered with a VC/ government funded Biotech who are looking for a Clinical Project Manager, to be the focal point within their Clinical Operations team (reporting directly in to the Head of Clinical Operations). The biotech is an infectious disease-focused biotech that currently has 4 programs that stem from pre-clinical to phase 1, so are much earlier in development. They have current funding which will last until the end of phase 2 on their main asset, with more funding expected to arrive in the meantime, so it’s a role that can definitely provide both stability and growth!
Responsibilities include:
- Participate in the development of clinical trial documents and manuals, including but not limited to Protocol, Informed Consent Forms, Laboratory Manual, Pharmacy Manual and other regulatory documents
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations
- Select, coordinate, and monitor activities of study vendors
- Manage evaluation and selection of investigational sites
- Review monitoring reports and conduct co-monitoring visits, as needed
- Assist study CRA and third-party vendor training on protocol and practices
- Oversee performance of CROs, third party vendors, and study CRAs to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalate to the VP, Clinical Operations
- Participate in the development and tracking of trial(s) timelines, budget and priorities
- Track and report on progress of clinical trial including site activation, patient accrual, monitoring visits
- Ensure appropriate clinical trial supplies are provided to investigational sites in due time with the support of CMC / Operation
- Contribute to clinical data review
- Participate in internal sub-team meetings, safety monitoring boards, CRO meetings
Qualifications:
- Master’s degree in biochemistry, biology, or any other health-related discipline
- At least three years of experience in the conduct and management of clinical trials
- Proficient with MS Office programs
- Fluent (spoken and written) in English
