Clinical Program Manager
The Clinical Program Manager (CPM) is accountable for the on-time delivery of a clinical program for an assigned Therapeutic Area.
The CPM is responsible for clinical operational planning activities and is accountable for leading program/study execution. The CPM leads one or more studies and may take on additional responsibilities as dictated by project size and complexity with minimal oversight. The CPM provides overall clinical project management, leads the cross-functional study execution team (SET) and coordinates study execution at the global level. The CPM oversees program/study level outsourcing, takes preventive/corrective action(s) to address study/program level issues.
1. Plan, manage and execute clinical programs
•Responsible for the project management of a clinical program/study
•Create and drive study level timeline
•Develop overall feasibility concept and enrollment plan with input from COMs
•Develop and manage study budget
•Provide input on operational aspects of the protocol
•Ensure regulatory compliance and GCP compliance
•Responsible for oversight of TMF with periodic audits
•Responsible for leading vendor selection and management including issue escalation
•Develop and implement Study Management plan and all associated documents (i.e. vendor oversight plan)
•Collaborate with CTS team to plan and coordinate IMP and non-IMP supplies
•Plan, lead, and facilitate SET (internal) meetings as well as act as the CSL lead for vendor meetings
•Ensure monitoring plan is developed and consistently executed in collaboration with COMs.
•Develop proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
•Consults with COMs for strategic selection of countries and sites
•Facilitate and coordinate communications with external provider
•Ensure Clinical Operations team and external provider receive study specific training
•Report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
•Facilitate study close out activities through completion of Clinical Study Report
2. Provide operational input into the overall program strategy.
3. Act as the primary point of contact for internal groups outside of CRD (including Regulatory, Commercial Development and Project Management) for program/study specific information.
4. Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
5. Ensure standard processes, tools and procedures are used consistently for study execution.
Education
At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
Requirements:
Experience:
Essential Experience
• As a guide, a minimum of 6+ years relevant clinical research experience within the pharmaceutical industry.
• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
• Experience in overseeing global clinical trials (pharmaceutical or research institute).
• Budget forecasting and management.
• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
Desired Attributes – The following are considered desirable:
• Postgraduate qualifications.
• Experience in scientific/medical research.
• Specialist knowledge e.g. immunology, coagulation disorders, pulmonology, virology, oncology and cardiology.
• Demonstrated proficiency in advanced MS Project.
Worker Type:
Employee
Worker Sub Type:
Regular
