Description:
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 companies 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
Requirements:
- Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum
- Minimum 5 years of experience in the pharmaceutical industry in the pharmaceutical industry in a position performing clinical operations functions.
- Experience working on large, global studies with multiple vendors involving management of submission timelines and associated processes
- 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
- CNS experience preferred but not required
- Excellent written and verbal communication skills
Job Qualifications BS/MS Degree in related field required
Experience in clinical operations methods and processes in industry setting required
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