Clinical Trial Manager
- Posted: over a month ago
This position is responsible for the planning and oversight of clinical studies and GCP related activities for several programs simultaneously, providing leadership and consultation within the department, across divisions, and to external clients. Assignments include protocol development, study management, development team leadership, SOP development, and supervision of indirect reports.
Essential Duties & Responsibilities
- Independently perform or guide clinical activities on programs consisting of multiple studies running simultaneously.
- Serve as a direct study manager on a portion of studies within a program, fulfilling all associated duties.
- Oversee activities of full-time and contract CRAs for assigned studies; interact with CROs, provide guidance to CRO personnel and negotiate sponsor/CRO relationships if appropriate.
- Responsible for managing the conduct of single and multi-center studies and study activities such as study design, protocol preparation, investigator selection, investigator meeting, budget and contract preparation, negotiate final budgets with investigators and/or institutions, and development of monitoring/communication/enrollment plans.
- Review and approve monitoring visit reports, regulatory documents, and other key study records.
- Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed.
- Contribute to authorship of study protocol(s) and coordination of clinical activities across all assigned studies.
- Assist in the preparation of Case Report Forms, monitoring and data management tools and other study documents.
- Represent Clinical Operations on cross-functional project teams.
- Oversee clinical processes to ensure timelines are met.
- Identify and oversee resource requirements with team and Sr. Director Clinical Operations.
- Organize, oversee and implement protocol training and other supportive activities at Investigator meetings.
- Provide input related to the preparation of Investigational New Drug (IND) Applications, Biologic License Applications (BLA), Sponsor’s Clinical Reports, Annual Progress Reports, manuscripts and regulatory submissions related to clinical content.
- Provide supervision to indirect reports, including employee development, resourcing, annual performance evaluations, and ongoing performance feedback and assuming a leadership role in training and mentoring less experienced personnel.
- Actively participate in project and strategic planning.
- Maintain expertise in relevant areas of government and industry regulations and clinical science and apply knowledge by leading the development of cross-functional process improvement activities and training program.
- Identify and manage contract monitors and contract research organizations.
- Identify and manage other vendors such as central labs, interactive response providers, recruitment services, meeting planners, clinical supply services, etc. as needed to meet study objectives.
- Provide recommendations regarding monitoring safety, eligibility, enrollment and data consistency for assigned studies.
Skills & Abilities
- Capable of formulating a clinical project plan based upon literature, input from internal and external experts, and own experience.
- Must have a demonstrated ability to guide programs having major division/staff importance to successful completion with minimal direction.
- Ability to manage vendor/contracts relationships.
- Must have demonstrated the ability to interact with peers and senior staff members and maintain good interpersonal working relationships.
- Strategic thinking and strong decision making capability
- Bachelors scientific/technical discipline,
- Pharmacy, Biological Sciences, Chemistry, or other appropriate
Minimum Years of Experience
- 6 years degree requirement if time in roles and progression of clinical research - Equivalent clinical research experience may be considered
- Clinical research, with a previous clinical trial assistant, study coordinating or 5 years Preferred project management support at a sponsor or CRO
- 4 year of Knowledge of GCP guidelines and regulations - Required
Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.
BioTissue Holdings Inc
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