We have other current jobs related to this field that you can find below
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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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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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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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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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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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Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring 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, Clinical Operations and is accountable to the Clinical Operations...
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Cambridge, United States Moderna, Inc. Full timeThe Role:The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring 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, Clinical Operations and is accountable to the Clinical Operations...
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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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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, 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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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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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...
Clinical Trial Assistant
2 months ago
Vericel 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. Reporting directly to Clinical Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Clinical Trial Assistant plays a critical role in the clinical department by ensuring the accuracy, completeness, and compliance of clinical trial documentation. This role involves collaborating with various stakeholders to maintain high-quality documentation standards in accordance with regulatory requirements and organizational policies. The ideal candidate will possess strong attention to detail, exceptional organizational skills and a thorough understanding of clinical trial processes. The position is office-based in Cambridge, MA.
DUTIES AND RESPONSIBILITIES
Essential Functions:
- Prepares investigator site files, trial master files (TMF) and electronic trial master files (eTMF) for the initiation of participating centers in clinical studies.
- Collects, registers and archives information and documents in accordance with the applicable good clinical practice guidelines for clinical studies.
- Reviews and analyze clinical trial documentation to ensure accuracy, completeness and compliance with regulatory standards and organizational guidelines.
- Collaborates with clinical research teams, investigators, and other stakeholders to resolve documentation discrepancies and ensure data integrity.
- Works closely with the Clinical Project Manager and is mentored to uphold a strong project foundation and support during challenges.
- Maintains comprehensive documentation of all clinical trial activities, including protocols, informed consent forms, case report forms, and study reports.
- Assists in the development and implementation of document management systems and processes to streamline document workflows and enhance efficiency.
- Performs quality control checks on clinical trial documentation to identify errors or inconsistencies and implement corrective actions as necessary.
- Provide ongoing status reports to the Clinical Project Manager to align on project metrics.
- Supports the Clinical Department in Administrative tasks and meeting department and project deadlines.
- Takes on department-wide tasks to contribute to the optimization of processes within the department.
- Supports the Clinical Project Manager with vendor negotiations.
- Provides support during regulatory inspections and audits by preparing and organizing documentation for review.
- Stays updated on relevant regulations, guidelines, and best practices in clinical research documentation to ensure compliance and continuous improvement.
- Participates in cross-functional team and training initiatives to promote knowledge sharing and collaboration across the organization.
Leadership Responsibilities:
- Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- Associate’s degree in life sciences, health informatics, or related field. Bachelor’s degree preferred.
- Minimum 2 -5 years in clinical research, documentation management, preferably in a research or healthcare setting.
- Strong understanding of regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations)
- Proficiency in document management systems and software applications (e.g., Microsoft Office, electronic data capture systems).
- Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and convey complex information clearly and concisely.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and prioritize tasks in a fast-paced environment while maintaining high standards of accuracy and quality.
- Certification as a Clinical Research Associate (CCRA) is preferred but not required.
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
