Clinical Project Lead IV
- Boston, MA
Clinical Project Lead (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors.
- Direct the execution of clinical trial activities in accordance with Client SOPs, ICH Guidelines, and Good Clinical Practice (GCP).
- Ensure compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection.
- Lead cross functional clinical study team and interact with internal and external groups to achieve study milestones.
- Determine study requirements, define specifications, and initiate and lead the selection of third party vendors.
- Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality.
- Communicate clinical studies performance data to other members of the management and scientific team.
- Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets.
- Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
9+ Years of ExperienceEducation:
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug developmen
Wednesday, May 29, 2019