Title: Senior Clinical Project Manager
Company Summary:
A phase II & III pharmaceutical company focused on the endocannabinoid system and the development of oral therapeutics to treat/regulate inflammation and fibrosis in the body. The Senior Clinical Project Manager will be responsible for the execution of clinical trials and the completion of study deliverables. You will play a key role in identifying/resolving clinical project issues and make a direct impact on the development of the clinical trials.
The Senior Clinical Project Manager will be responsible for;
- Study timelines and metrics
- management of study budget
- Project debriefings
- Lead study-specific meetings
- Vendor Management
- Leadership and study-specific training to staff
- Identify risks, resolves issues w/ CRO's, and establish vendor management plans
- Review quality metrics
- Site selection and management
- Prepare site study docs
- Review study tools and worksheets
- Prepare investigator contracts and site payments
- Develop data plan for data trend detection
- Coordination with Clinical Supply to facilitate study drug manufacturing
- Audit for clinical trial documents
- Coordination with regulatory and ethics committee
- Lead cross-functional study team internally and externally
The Senior Clinical Project Manager Should Have the Following Qualifications;
- Bachelor's Degree in Bio Sciences; Master's Preferred
- Min 4 years clinical study management in biopharma industry
- 2+ years as clinical study lead/Project Manager
- Experience managing CRO
- Clinical quality compliance
- GCP and ICH Knowledge
- Communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required
If you are intrested in the Senior Clinical Project Manager role the please do not wait to apply!
