We have other current jobs related to this field that you can find below
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Manager, Clinical Trial Transparency
4 weeks ago
Cambridge, United States Moderna, Inc. Full timeThe Role:The Manager of CTTD is a key role within our organization, reporting directly to the Director of CTTD. This position is responsible for managing the development and delivery of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual in this role will work closely with the clinical development...
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Manager, Clinical Trial Transparency
4 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Manager of CTTD is a key role within our organization, reporting directly to the Director of CTTD. This position is responsible for managing the development and delivery of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual in this role will work closely with the clinical development...
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Senior Clinical Trial Manager
3 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 days 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
1 day 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
4 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 Assistant
1 day ago
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJob DescriptionJob DescriptionJoin Beacon Therapeutics (USA) Inc as a Senior Clinical Trial Assistant and elevate your career in the dynamic biotech industry! This role offers the excitement of working on groundbreaking clinical trials providing the flexibility to balance your professional and personal life. Immerse yourself in a culture that values...
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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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Senior Clinical Trial Manager
2 months 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
2 months 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 Specialist
5 days ago
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionCompany DescriptionHI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while...
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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 days 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
3 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
1 day 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
4 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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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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Clinical Trial Specialist
4 days ago
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionCompany DescriptionHI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while...
Senior Manager, Clinical Trial Transparency and Disclosure
2 months ago
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 activities (e.g., clinical trial results postings, document redactions, and layperson results summaries). The Senior Manager will partner with and lead interactions with senior management and team members in relevant functional areas and manage vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.
Key Responsibilities
- Lead Global Clinical Trials Transparency Workstream and provide vendor oversight
- If needed, lead the development of Cerevel’s overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary
- Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations
- Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends
- Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (e.g., plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teams
- Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans
- Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents
- Lead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as needed
- Advise on lean writing practices for regulatory documents such as clinical trial protocols and Clinical Study Reports to minimize CCI and PPD
- Act as a subject matter expert during regulatory inspections
Required Qualifications
- Minimum of 6 years experience in the biotech or pharma industry; including a minimum of 4 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience
- Experience writing or managing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)
- Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations
- Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)
- Experience working with CTIS preferred
- Understands the clinical drug development process, including clinical trial design, operations and results analysis
- Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support
- Ability to evaluate and recommend process improvement and suggest/implement best practices
- Outstanding oral and written communication skills
- Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize
- Flexible; adapts work style to meet organization needs
- Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite
Desired Qualifications
- Recent neuroscience experience (within 2 years)
- Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects
- Prior experience working in Clinical Development, Clinical Operations, or Medical Writing
Education
- Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred
