Title: Clinical Project Manager III
Location: Lexington, MA, United States
Duration: 06+ Months
Job Details:
• Responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
• Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc.
• May author, review and approve various study related documents and plans.
• Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
• Leads cross-functional team and is responsible for the financial management of the study (ies).
Responsibilities
% of Time Job Function and Description
10 %:
• Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
• Authors/contributes to clinical study documents.
• Reviews and approves study related plans generated by Clinical CROs and vendors
• Provides input as the subject matter expert for the study during regulatory inspections.
• 40%
• Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan
• Responsible for oversight of identification and selection of investigator sites.
• Responsible for planning and conducting investigator's meetings.
• Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team.
• Collaborates with the cross-functional team on selection and management of clinical vendors.
• Liaises and coordinates with document specialists regarding study files.
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
40 %:
• Trains and manages CRO and other clinical vendor activities to ensure the quality meets Client and regulatory requirements.
• Monitors the status of clinical data collection of assigned clinical studies.
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
• Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
• Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact.
• Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO.
• Reviews correspondence and monitoring reports relating to the study.
• Evaluates CRO and vendor performance for future work.
• Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Programs Lead (CPL) as requested.
5%:
• Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable).
• Requests and critically evaluates proposals and change orders from CROs and vendors.
• Leads team through selection process and provides input into contracts, change orders, and/or work orders.
5%:
• Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
• Supports department initiatives and process improvements.
• May mentor other Study Managers.