Senior Clinical Project Manager - Oncology Biotech

Job title : Senior Clinical Project Manager - Oncology Biotech
Location : Oxfordshire, England
Job type : Permanent
Salary : £80000 - £90000 per annum + Annual bonus, health care plan
Contact name : Roy Nelson
Contact number : +44 (0) 207 255 6620
Contact email : roy.nelson@seclifesciences.com
SEC Life Sciences is advertising an exciting opportunity for a Senior Clinical Project Manager to lead multiple studies of an exciting clinical-stage biotechnology company's Immuno-Oncology program pipeline.

The role consists on providing overall management and accountability of complex, large, multi-centre studies from developing study documents through to monitoring study progress and overseeing study budgets. This is an inclusive role whereby your existing project management skills will serve to mentor trial managers and participate in process improvement initiatives, ensuring adherence to ICG-GCP guidelines and regulatory requirements.


Main responsibilities (not limited to):

- Overall accountability and oversight of programs to ensure deliverables and milestones are attained within scope, budget and high-quality standards.
- Manage, select and review third-party vendors, including CRO oversight.
- Manage and develop study budgets, forecast expenditure with view of ensuring costs align with predicted costs.
- Manage, review and approve change orders.
- Contribute to authoring study protocols, protocol amendments and other related study documents, as required, from the initial scientific discussion.
- Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection.
- Play an active role in the contribution of IND and other regulatory documents.


Key Skills:

- Vendor oversight experience
- Rapport building and relationship building skills
- Effective communication skills and coordination of activities with the internal team, clinical sites and vendors.

Requirement:

- Minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience.
- Proven track-record of project management experience of global clinical trials in Oncology (ideally).
- Experience of conduct and management of multinational clinical trials.
- CRO/Vendor management experience.
- In-depth knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.
- Proficient with ICH/GCP guidelines.

Apply:

1) To apply, please send your CV to Roy at roy.nelson@seclifesciences.com briefly outlining your study/project management experience and suitability for the role. For further information call +44 207 255 66 20.

2) Click the Apply entry on this page

SEC Life Sciences is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, bio-pharmaceutical, biotechnology and medical device companies.