Senior Manager, Clinical Operations, NBG in Hertfordshire

03 Jan 2019
31 Jan 2019
Contract Type
Russell Oakley is recruiting for a Senior Manager, Clinical Operations in Neurology on a 6 month contract with a well established and successful international pharma company based in Hertfordshire.

The Role:
The Senior Manager, Clinical Operations is responsible for the management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing. The immediate need is for the Sr. Manager, Clinical Operations to support two (2) pivotal Phase III global studies for a major submission within the company's Neurology Business Group. This is an exciting opportunity for an individual with demonstrated learning agility to work on a large, high profile global program. This position works with other team members to coordinate preparation of study protocols and final study reports. A detailed understanding of overall strategic direction, interrelationships and business needs is required.

- Managing all aspects of study progress from start-up to close-out activities, and assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.
- Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing.
- Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals).
- Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
- Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
- Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution.
- Contributing to individual and team development through training initiatives and team building activities.

Your Background:
- Demonstrated experience in the Pharmaceutical industry in a clinical operations function.
- Experience working on large, global studies with multiple vendors involving management of submission timelines & associated processes.
- Demonstrated experience in identification of emerging risks & the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required.
- Solid project & vendor management, analytical & problem solving skills.
- Prior experience in development and tracking of study budgets in excess of $20M.
- CNS experience preferred but no required.
- Excellent written & verbal communication skills.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL44282 in all correspondence.

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