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.
- 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.
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.