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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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Senior Manager, Clinical Trial Transparency and Disclosure
1 month 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 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
