- Perform day to day management and oversight of assigned clinical trial to ensure deliverables are met timely and within budget
- Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Develop and maintain study level timelines and budget with internal leadership and CRO
- Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
- Responsible for ongoing study communication and escalation of study-related issues as required
- Develop and adhere to vendor oversight plans
- Contribute to or author relevant study documents such as the protocol, informed consent form, investigator brochure, clinical study reports and other documents and plans, as appropriate
- Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)).
- Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
- Oversight and review of data management outputs
- Responsible for protocol deviation review and listing
- Participate in and provide feedback during RFI, RFP and bid defense process for new studies
- Participate and review quality plans and audit reports for the study and provide oversight of CAPA resolution with the CRO, vendors and sites, as needed
- Oversee any subcontracted vendors through CRO
- Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
- Oversight of the eTMF for the trial and will ensure an audit/inspection ready Participate and review SOPs for clinical operations and other functional areas as needed
- Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
- Support during relevant inspections (e.g., FDA)
- Assist CRO with planning of Investigator Meetings and associated travel
- Facilitate review of clinical trial agreements
- Identifies potential risks form study and works with the team to resolve any issues
- Participates in UATs, e.g., EDC, IRT
- Mentoring assigned Clinical Trial Coordinator
- Bachelor's degree in the Life Sciences or equivalent is required
- 8 years of experience in clinical operations is required
- Ability to build strong relationships with the sites and CRO including providing feedback as well as oversight
- Passion for working in a small company environment - including being self-motivated and proactive
- Ability to think of big picture as well as being adept at detail-orientation
- Up to 20% travel may be required
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Clinical Trial Manager
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
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Manager of Clinical Trial Supplies
1 week ago
Whitridge Associates Cambridge, United StatesResponsibilities: · Develop clinical supply strategy in conjunction with Clinical Team · Work with the Clinical and Regulatory Teams to ensure that the label texts for each territory involved in a clinical trial meet requirements · Work with the Clinical and CMC Teams to ensure t ...
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Sr. Clinical Trial Manager
2 weeks ago
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Senior Clinical Trials Manager
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Sr. Clinical Trial Manager
2 weeks ago
Moderna Theraputics Cambridge, United StatesThe Role · The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing.Strong vendor management is critical for ...
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Senior Clinical Trial Manager
3 weeks ago
Boston Pharmaceuticals Cambridge, United StatesCompany Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...
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Fusion Pharmaceuticals LLC Cambridge, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
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Associate Director, Clinical Trial Manager
2 weeks ago
BlueRock Therapeutics Cambridge, United StatesWho is BlueRock? · BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generati ...
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Associate Director, Clinical Trial Manager
2 weeks ago
BlueRock Therapeutics Cambridge, United StatesWho is BlueRock?BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation o ...
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Clinical Trial Manager
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Beacon Hill Boston, United StatesPosition Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and ...
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Sr. Manager, Clinical Trial Transparency
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Moderna Theraputics Cambridge, United StatesThe Role: · The Senior Manager of Clinical Trial Transparency & Disclosure is a high-impact role, reporting directly to the Director of CTTD. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from th ...
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Sr./Clinical Trial Manager
3 weeks ago
Apex Systems Watertown, 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 cont ...
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Clinical Trial Manager
2 weeks ago
Dragonfly Therapeutics Waltham, United StatesClinical Trial Manager · Dragonfly 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 ...
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Clinical Trial Manager
2 weeks 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 ...
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition 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 Opera ...
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Clinical Trial Manager
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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 ...
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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 ...
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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 ...
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition 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 Manager to join our Clinical Operati ...
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Clinical Trial Manager
3 weeks ago
Alkermes Waltham, United StatesJob Description · Position Summary: · Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · Responsibilities · Clinical project team member: works closely with the Sr. CTM and/or Clinical Pro ...
Associate Director, Clinical Trial Manager - Cambridge, United States - BlueRock Therapeutics
Description
This position will lead a cross-functional clinical development team to ensure the successful planning, execution, and close-out of an upcoming Phase 1/2a clinical study and other studies, as needed. This individual will manage and oversee internal and external study activities, managing and overseeing a CRO and other vendors. The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Operations.Responsibilities:
