A large pharmaceutical company, headquartered in the USA, is searching for a Senior Manager of Clinical Operations to join their team in Edison, New Jersey. The company focuses on areas such as neurology and oncology, and employs thousands in many countries all over the world.
- 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 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
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.