Contract Clinical Program Director
An exciting opportunity has arisen for a contract Clinical Program Director to lead a Global Project Team. You will work with the development team to design operational inputs but also develop programme strategy.
- Plans, directs and delivers the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned KPIs
- Leads and delivers differentiated and robust operational options for review at Investment Decision Governance interactions
- Leads operational discussions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
- Develops and maintains effective program level risk management/mitigation plans to ensure timely delivery to quality and budget
- Accountable for planning and leading issue escalation and resolution
- Accountable for the acquisition of clinical trial data from internal and external sources
- Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Accountable for the quality of study delivery planning information into relevant planning systems
- Accountable for coordination of selection of external providers for programme/study specific tasks
- Provision to procurement of clear specifications for program/study specific outsourcing
- Review and operational approval of program/study specific contracts or work orders
- Operational management and oversight of external providers at program/study level
- Engagement with preclinical and translational science as well as statistics and regulatory in order to design and deliver robust clinical development plans.
Skills and Requirements
- Minimum BA/BSc
- At least three years' relevant experience in clinical development including team leadership.
- Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies from study start-up to study report completion.
- A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.