Company: Barrington James Clinical
Location: England - Homebased
Closing Date: 07 Mar 17
Salary (£): Competitive
Benefits: Great Benefits
We are currently a partnering a niche privately owned biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets.
We are currently a partnering a niche privately owned biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets. This is an exciting opportunity to work directly for a growing biotech company that are expanding across the EU.
The Clinical Project Manager (CPM) will be responsible for the operational and logistic aspects of the assigned clinical program(s). Within this role, the CPM will be responsible for adhering to regular planning of tasks in accordance with clinical program timelines, performing the required activities to keep the assigned clinical program(s) on budget, on time and with the highest standard of quality. In addition, the CPM will be the primary point of contact for any program related issue, both internally and with external stakeholders.
Most important tasks of the job:
Implement, monitor, supervise and direct the assigned Clinical program(s)
Ensure all program deliverables are met according to timelines, budget, operational procedures and quality / GCP standards
Supervise maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and internal Standard Operating Procedures (SOPs)
Streamline interactions with relevant internal functions, by leading and coordinating the Clinical Project Team
Keep regular interaction with CRO and trial sites to ensure sponsor’s oversight responsibilities
Develop / prepare relevant sections of clinical trial protocols and related documents in collaboration with internal stakeholder and CROs
Develop clinical sections of regulatory documents
Prepare and share information (e.g. PowerPoint slides, Word document, Excel Spreadsheets) about clinical trial updates for internal and external team meetings (e.g. regular updates, CRA training, Investigator’s meeting)
Support the Head of Clinical Operations (Head Clinops) activities when necessary
Keep tracking of program budget, reviewing and approving invoices
Implement and update / improve policies, SOPs and Work Instructions (WIs), as required
Qualification and Experience:
Languages: Fluent in English, both written and verbal. Any additional language is a “nice to have“.
Experience: 7+ years in relevant functions in the Pharmaceutical Industry, or equivalent. Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required. Subject matter expertise in clinical operations and related activities. Previous experience conducting clinical trials in Europe/US and some Asia-Pacific regions in an outsourcing model is necessary, along with a working knowledge of the EMEA and FDA clinical/regulatory environment.
As a team player you manage to build a team spirit. You are tolerant and considerate to be an active and open communicator and share knowledge and experience with other team members. You have a hands – on attitude as well as a result-orientated way of work. You coordinate, participate and make positive contribution to team meetings.
If you are interested in learning more about this exciting opportunity, then please do not hesitate to reach out to me directly!
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