We have other current jobs related to this field that you can find below
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Senior Clinical Trial Manager
2 weeks ago
Cambridge, United States Pheon Therapeutics Full timeResponsibilities:Pheon’s Senior Clinical Trial Manager / Associate Director will collaborate with Pheon’s Head of Clinical Development to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure. Independently lead Clinical Operations activities for one or...
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Senior Clinical Trial Manager
2 weeks ago
Cambridge, United States Pheon Therapeutics Full timeResponsibilities:Pheon’s Senior Clinical Trial Manager / Associate Director will collaborate with Pheon’s Head of Clinical Development to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure. Independently lead Clinical Operations activities for one or...
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Sr. Clinical Trial Associate
2 weeks ago
Cambridge, United States Adecco Full timeA Sr. Clinical Trial Associate position in Cambridge or Bedford, MA is now available through Adecco Healthcare and Life Science. In this role, you will be responsible for administering, maintaining, and coordinating the logistical aspects of clinical trials. The Sr. CTA will provide support during clinical study planning and execution, including management...
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Senior Clinical Trial Manager
2 months ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...
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Cambridge, Massachusetts, United States Cerevel Therapeutics Full timeRole Summary:The Senior Manager of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevel's transparency and disclosure...
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Cambridge, United States Cerevel Therapeutics Full timeRole Summary: The Senior Manager of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevel’s transparency and disclosure...
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Senior Clinical Trial Manager
1 month ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
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Senior Clinical Trial Manager
1 month ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
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Clinical Trial Lead
3 weeks ago
Cambridge, United States Pheon Therapeutics Full timeResponsibilities:Pheon’s Clinical Trial Lead / Senior Clinical Trial Manager will collaborate with Pheon’s Head of Clinical Development to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure.Lead Clinical Operations activities for one or more of...
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Clinical Trial Lead
3 weeks ago
Cambridge, United States Pheon Therapeutics Full timeResponsibilities:Pheon’s Clinical Trial Lead / Senior Clinical Trial Manager will collaborate with Pheon’s Head of Clinical Development to provide key operational oversight and support of all clinical trial activities including vendor oversight and management, from study initiation to closure.Lead Clinical Operations activities for one or more of...
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Clinical Trial Assistant
3 months ago
Cambridge, United States Vericel Corporation Full timeJob DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing clinical professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics....
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Cambridge, United States Moderna, Inc. Full timeThe Role:The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s).This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). with external vendors and CROs.The position...
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Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s).This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). with external vendors and CROs.The position...
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Clinical Trial Manager
2 months ago
Cambridge, United States Simcere Zaiming Full timeCompany 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 worldwide. Our culture values sincerity, collaboration, result orientation, and a...
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Clinical Trial Manager
2 months ago
Cambridge, United States Simcere Zaiming Full timeCompany 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 worldwide. Our culture values sincerity, collaboration, result orientation, and a...
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Cambridge, United States findojobs.us Full timeThe RoleThe 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 this role. external vendors and CROs. The position may report to the Sr. Director,...
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Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe RoleThe 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 this role. external vendors and CROs. The position may report to the Sr. Director,...
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Cambridge, United States Moderna, Inc. Full timeThe RoleThe 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 this role. external vendors and CROs. The position may report to the Sr. Director,...
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Cambridge, United States Moderna, Inc. Full timeThe 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 this role. external vendors and CROs.The position reports to the Director,...
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VP, Clinical Trial Excellence
3 months ago
Cambridge, United States Moderna, Inc. Full timeThe Role:The Vice President, Clinical Trial Excellence & Delivery is a strategic leader responsible for the design, oversight, and execution of clinical trial processes that enhance efficiency, innovation, and operational excellence across the Development portfolio. This individual will be a key voice within the Leadership Team, helping the CDO LT shape the...
Senior Clinical Trial Associate
2 months ago
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.Summary:
The Senior Clinical Trial Associate is responsible for supporting the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This position is located in Boston, MA.
Responsibilities:
- Clinical study team member working closely with the Clinical Trial Manager (CTM) and Head of Clinical Operations and is responsible for coordination and tracking of study logistics in support of clinical trials.
- With CTM oversight, assists with tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the CTM and Finance.
- Works closely with CTM and legal to review and approve clinical trial agreements and site specific study budgets.
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
- With CTM oversight, reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
- Responsible for and/or aids CRO in set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files in accordance with eTMF plan.
- Coordinates TMF transfer with CROs.
- Responsible for maintenance of internal SharePoint and Box files.
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues and escalates to CTM as needed.
- Assists CTM in review and approval of informed consent templates.
- Responsible for agendas, meeting minutes, and tracking action items for clinical study team meetings.
- Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CTM and external meeting planners.
- Responsible for set-up and management of ClinicalTrials.gov.
Qualifications
- BA/BS (preferably in industry or healthcare of science field).
- Ability to handle a high volume of highly complex tasks within a given timeline.
- Excellent interpersonal and negotiation skills
- Strong verbal and written communication and presentation skills
- Proficient in Microsoft programs such as Word, Excel, PowerPoint
- Proactively seeks out and recommends process improvements
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
PDN-9c604210-d7b6-4ec6-8ee6-dc686fc7d560