Senior Manager, Clinical Operations - Herfordshire
Russell Oakley is recruiting for an Senior Manager in Clinical Operations, Neurology to join a Pharmaceutical company at their site based in Hertfordshire on a permanent basis.
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 Senior Manager, Clinical Operations to support two (2) pivotal Phase III global studies for a major submission within the 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.
Responsibilities include but are not limited to:
- 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
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BS/MS in relevant field
- Experience in clinical operations methods and processes in an industry setting.
For more information or to apply for this position, please contact Russell Oakley on 01246 457709 or email firstname.lastname@example.org Alternatively, please click on the link below to apply online now. 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 CL41910 in all correspondence.