The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position reports to the Senior Director, Clinical Operations, Infectious disease and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
Here’s What You’ll Do:
- Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
- Communication to internal team members on deliverables and ensuring timelines are met
- Manage trial feasibility process
- Work closely with study Clinical Operations Lead to execute clinical studies.
- Drafting site materials including training, manuals and support documentation.
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
- Periodic review of clinical data
- Review of clinical monitoring reports to ensure timely completion and identification of issues
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
- Maintain trial metrics
- Ensure trial is conducted in accordance to our client and ICH/GCP standards including multiple regions in global trials
- Support testing clinical trial systems/databases (i.e. UAT)
- Develop and maintain strong, collaborative relationships with key stakeholders
Here’s What You’ll Bring to the Table:
- At least 5 five years of trial coordination experience in a clinical research environment; phase 3 experience desired. Min 2 years clinical trial management experience.
- Advanced degree preferred or Bachelor’s in a science-based subject
- Relevant experience in global setting
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail