Clinical Program Manager/Senior Clinical Program Manager
Clinical Program Manager/Senior Clinical Program Manager
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Job Description
Clinical Program Manager/Senior Clinical Program Manager
About Us:
Position Summary:
Timberlyne is seeking a Clinical Program Manager (CPM) to join the Clinical Operations team. This individual will be responsible for the management of global clinical programs. They will lead the study team vendors clinical monitors and clinical sites throughout the life cycle of a clinical program.
This individual will be able to manage multiple study teams across a program and have broad involvement in work central to Timberlynes strategic goals. They will apply existing technical skills learn new skills and play a key role in the development of the programs and help grow the company and guide its direction.
CPM is responsible for the successful implementation of a clinical program including providing mentorship and oversight of all aspects of global clinical trials within designated program budgets and timelines. Experience in leading staff as well as mentoring and developing junior staff will be essential to the teams success. The CPM will represent Clinical Operations at Project team meetings and may represent Timberlyne at professional events.
Essential Responsibilities:
- Accountable for all operational aspects of clinical trials within the assigned program
- Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
- Examine functional issues from a broader organizational perspective and develop a strategy to implement with a cross-functional team
- Provides oversight to vendors including CRO central lab EDC/IRT systems etc.
- Proactively identifies potential issues/risks across the program and recommends/implements solutions.
- Participates in the selection training and evaluation of clinical trial managers and clinical trial management associates to ensure the efficient operation of the function.
- Attends and presents at cross-functional meetings as needed to represent Clinical Operations and program level items
- Provides mentorship and career development to direct reports.
- Provides leadership to the clinical operations team working on the assigned program.
Skills and Experience:
- BS. or B.A. in biological sciences advanced degree preferred with 8 years of relevant industry experience
- Ability to travel as required for the program (10-15%)
- Demonstrated knowledge of FDA ICH and GCP regulations and guidelines
- Experience in leading teams including CROs consultants and vendors.
- Proficient in developing trial plans and implementing operational changes across multiple studies
- Highly developed leadership skills to successfully lead multiple direct reports
- Must display strong analytical and problem-solving skills at a program level and collaborate with colleagues to generate solutions
- Strong communication and influence skills and ability to create a clear sense of direction
- Ability to deal with time demands incomplete information or unexpected events
- Outstanding organizational skills with the ability to multi-task and prioritize
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
How To Apply: Please send your resume to
All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity/expression national origin disability medical condition age marital status status as a protected veteran or any other legally protected characteristic.
Required Experience:
Manager
Employment Type
Full Time
