Senior Manager; Clinical Operations
The Senior Manager, Clinical Operations is responsible for the overall 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.
This is an exciting opportunity for an individual with demonstrated learning agility to lead studies in several high profile global programs.
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 to assuring adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.
- 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.
- Collaborating with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
- Overseeing 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
What are we looking for?
- Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum
- Demonstrated experience in the pharmaceutical industry leading large, global studies with multiple vendors involving management of submission timelines and associated processes
- Prior experience as a field monitor/ CRA
- Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required
- Solid project and vendor management, analytical and problem solving skills
- Prior experience with development and tracking of study budgets in excess of $20M
- Excellent written and verbal communication skills
- CNS experience preferred Epilepsy or AD/Dementia
STR Limited is acting as an Employment Agency in relation to this vacancy.
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