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Job type: Contract

Discipline: Program Manager / Director

Location: United Kingdom

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.

Job Responsibilities

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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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