I’m partnered with a Bio Pharmaceutical with an exciting project, they are looking for a Clinical Program Manager to work within the Inflammation Therapeutic Area and join their team in West London for 12-month contract.
- Successfully manage all aspects of assigned clinical studies within designated program budgets and timelines.
- include protocol development, feasibility, set-up and conduct, CRO selection and oversight and reporting according to SOPs and appropriate national and/or global regulation and legislation.
- To collaborate with colleagues in Clinical Operations, Medical Affairs, Drug Safety, Project Management, Regulatory and Clinical Research within the EU and US as required to ensure delivery of assigned studies as well as support assessment and tracking of trials.
- Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.
- Develop RFPs, select CROs/vendors, and manages external resources.
- Communicate project status and issues and ensure project team goals are met.
- Participate in development of SOPs, Clinical Study Reports and other clinical, regulatory and safety documents.
- Contribute to development of abstracts, presentations, and manuscripts.
- Develop good working relationships with US and cross-functional teams.
- Manage assigned regional/European projects/initiatives as specifically delegated.
- Conduct study feasibility in conjunction with internal European Clinical Operations staff and/or external collaborators or CROs.
- Actively lead Study Management Teams (SMTs) for assigned studies or participate on US based SMTs as necessary and provide strategic and operational advice as required.
- Actively participate in CRO study calls as appropriate.
- Maintain current knowledge of both local & regional legislation regarding execution of clinical trials.
- Actively participates in European Clinical Operations Management and team meetings and serve as an ambassador for Clinical Operations internally and externally.
- BSc Life Sciences. A MSc* or PhD would be advantageous.
- Minimum of 10 years relevant clinical experience in the pharmaceutical industry.
- Line management experience or experience in mentoring and developing junior staff would be preferred.
- Experience in clinical study management and project oversight is essential.
- Knowledge of regulatory affairs and drug safety.
- Experience in developing RFPs and selection and management of CROs/vendors.
- Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents with minimal supervision
- Therapeutic area (Inflammation) experience especially Rheumatoid Arthritis indication is preferred however not essential
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
- Fluency in English, including both oral and written communications. Proficiency in another European language(s) would be advantageous
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Extensive knowledge of ICH GCP, FDA and EMEA regulations & guidelines.
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
- Experience of working within matrix organisation.
- Finance and budgeting experience, resource management experience.
- Excellent understanding of clinical trial cycle times & associated metrics.
- Expertise in Inflammation therapeutic indication would be an advantage but is not essential.
Offering: 12 Month Contract working in west London with the level of travel explained above, paying 450 p/d
If this role sounds interesting, please get in touch via email or phone. Send your CV to Leanne@xplorepharma.com
This role is urgent, Interviews will happen as and when a great candidate gets in touch.
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