- 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
-
Clinical Trial Manager
5 days ago
CK Group Waltham, United StatesJocelyn Blackham is recruiting for a Clinical Trial Manager to join an exciting organization moving into the clinical stage for their work in the autoimmune disease, oncology, neuro-inflation and several other disease models. · Clinical Trial Manager role: · Providing trial mana ...
-
Clinical Trial Manager
5 days ago
BioSpace Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operati ...
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the executi ...
-
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
-
Clinical Trial Manager
6 hours ago
Staffmark Group Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
Senior Clinical Trial Manager
5 days ago
Warman O'Brien Waltham, United StatesSummary · We are looking for a Senior Clinical Trial Manager for a biotech client, based out of Waltham, MA. The Sr CTM is responsible for assisting in the execution and oversight of clinical trials in autoimmune disease. This position reports to the Associate Director of Clinica ...
-
Sr. Clinical Trial Manager
3 weeks ago
ClinLab Staffing Waltham, United StatesSenior Clinical Trial Manager · Waltham, MA · Summary · The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical ...
-
Senior Clinical Trial Manager
5 days ago
Birdseye Partners Waltham, United StatesSenior Clinical Trial Manager/CTM · Our client is a leading organization in the antibody driven Immuno-oncology space with a proven platform that has garnered multiple hundred-million dollar industry partnerships to drive their 5+ clinical trials. This company has multiple wholly ...
-
Clinical Trial Manager
6 hours ago
Alkermes Waltham, United StatesPosition Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I‐IV of development. ...
-
Senior Clinical Trial Manager
1 week ago
Meet Waltham, United StatesSenior Clinical Trial Manager - Oncology OR Rare Disease experience REQUIRED · Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or AD (based on experience) motivated ...
-
Senior Clinical Trial Manager
2 weeks ago
Cogent Biosciences, Inc. Waltham, United StatesWho We Are · Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to addre ...
-
Senior Clinical Trial Manager
1 week ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Senior Clinical Trial Manager is responsible for oversight and the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with minimal oversight from the Associate Direc ...
-
Senior Clinical Trial Manager
5 days ago
Visterra Waltham, United StatesJob Description · Job DescriptionSalary: · Summary · The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Op ...
-
Senior Clinical Trial Manager
6 hours ago
BioSpace Waltham, United StatesJob Details · Summary · The Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Operations. The ideal candidate ...
-
Sr./Clinical Trial Manager
6 hours ago
Stratacuity Waltham, United StatesSr. Clinical Trial Manager Location: Waltham, MA (Hybrid) Therapeutic Area: Auto Immune Job Overview: We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and contingency ...
-
Sr. Clinical Trial Manager 2019622
6 days ago
Stratacuity: Proven Scientific Placement Waltham, United StatesLocation: Waltham, MA (Hybrid) · Therapeutic Area: Auto Immune · Job Overview: We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and contingency plans in a fast-paced e ...
-
Clinical Trial Manager
5 days ago
Simcere Zaiming Cambridge, United StatesCompany Overview: · Simcere Zaiming is a pioneering pharmaceutical company dedicated to advancing healthcare through cutting-edge research and innovative therapies. With a focus on oncology drug development, we are committed to improving the lives of patients in China and worldwi ...
-
Senior Clinical Trial Manager 2032419
5 days ago
Stratacuity: Proven Scientific Placement Watertown, United StatesLocation: Watertown, MA (Hybrid/Remote) · Science: Small Molecule · Therapeutic Area: Oncology · Job Overview: This role entails managing oncology clinical trials from inception to Phase III, overseeing strategy, coordination, and compliance with timelines, budget, and standards. ...
-
Senior Clinical Trial Manager
1 week ago
C4 Therapeutics Inc Watertown, United StatesJob Description · Job DescriptionAbout C4 Therapeutics: · C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms pat ...
-
Clinical Trial Manager
3 weeks ago
Visterra, Inc. Waltham, United States Full timeSummary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operations. The ideal ...
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.
