- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Operational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Development/coordination of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
- Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Manage and lead site-facing meetings, including regular PI meetings, dose escalation meetings, and Investigator Meetings
- Attend study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetings
- Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
- Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)
- Bachelor's degree, or equivalent, in a biomedical, life science or related field of study
- Minimum of 3 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industry; Oncology/Immuno-oncology or immunology/inflammation experience required
- Good understanding of US regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategies
- Can communicate effectively
- Ability to influence and collaborate well with colleagues and partners in a fast-paced environment
- Ability and willingness to travel up to 15% of time
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Clinical Trial Manager - Waltham, United States - Dragonfly Therapeutics
Description
Clinical Trial ManagerDragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role will report to the Sr. Director, Clinical Operations. Job responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting to clinical development leadership, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks, and contingency planning.
Responsibilities:
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
