FREELANCE: Clinical Program Manager - Inflammation
- Experience Level
FREELANCE: Clinical Program Manager – Inflammation
12 month+ freelance contract
1-2 days home based, 3-4 days office based
James Carrera at Umbilical Life has partnered with a Global Pharmaceutical to hire a Freelance Clinical Program Manager within the Inflammation Therapeutic Area, to manage assigned studies to budget and timeline in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of the companies products.
- Successfully manage all aspects of assigned clinical studies within designated program budgets and timelines.
- 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 the US clinical operations team and cross-functional staff internationally as required.
- Manage assigned regional/European projects/initiatives as specifically delegated.
- Ensure local consistency & alignment with global process & procedure, whilst providing regional perspective & expertise to the US teams.
- May determine activities critical to company success and priorities within functional area.
- Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
- With limited supervision may participate in or lead departmental strategic initiatives.
- Travel may be required occasionally.
- Conducts study feasibility in conjunction with internal Clinical Operations staff and/or external collaborators or CROs.
- 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.
- Identify any “best practice“ opportunities to share across Therapy Areas and sites.
- 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.
Knowledge, Experience and Skills:
- Educated to degree level (MSc or PhD would be advantageous) you will have a minimum of 10 years relevant clinical experience in the pharmaceutical industry, with 2-3 years minimum program level experience as well as;
- Delivering; interim analyses, final data locks, CSR writing, study close out / budget reconciliation.
- Clinical study management and project oversight
- Management of CROs/vendors; developing RFPs and selection / management
- Knowledge of regulatory affairs and drug safety.
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
- Line management experience or experience in mentoring and developing junior staff would be preferred.
- Therapeutic area (Inflammation) experience especially Rheumatoid Arthritis indication is preferred however not essential
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