Senior Clinical Program Manager

Looking for a great opportunity to further your career?

Proclinical have a unique chance for a Senior Clinical Programme Manager to join one of the leading pharmaceutical companies in Surrey. This is a contracted role for phase I studies, with the possibility of an extension.

Job Responsibilities

• If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study.
• Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making.
• Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
• Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.
• Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
• Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.
• Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.
• Asia Specific - support any Regulatory Authority consultation activities.sm
• Provide study specific training for internal (i.e. UCB) and external (i.e. CRO, vendors, investigators) team members.
• A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.

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

A full job description is available on request.

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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