Senior Manager, Clinical Trial Disclosure and Transparency

The Senior Manager, Clinical Trial Disclosure and Transparency is a key member of the Clinical Trial Disclosure and Transparency (CTDT) team working within the Alnylam Medical Writing Expertise Area. The Senior Manager, CTDT is responsible for expertly carrying out operations for the accurate and timely disclosure of Alnylam trial information to regulatory agencies and publicly accessible clinical trial websites.

Key Responsibilities:

• Ensure accurate, timely, consistent, and complete disclosure of clinical trial information in alignment with global, regional, and local regulatory requirements.
• Independently plan and prepare data publication packages (e.g. Policy 0070, PRCI) to current guidelines, working closely with expert vendors to produce high quality and on-time deliverables.
• Oversee, track and facilitate Policy 0043 requests, collaborating with key Subject Matter Experts, vendors and regulatory stakeholders under short deadlines to ensure timely submissions. Maintain and continue to develop the Alnylam CCI library.
• Facilitate/manage the efficient review and finalization process for all anonymization packages and document redaction content with key stakeholders.
• Oversee or support in other key disclosure activities including redaction of clinical documents in preparation for EMA CTA submissions; planning and authoring of protocol registration records, and planning and authoring of results records.
• Serve as systems expert with deep understanding of Alnylam’s transparency tracking and authoring tool, clinical trial website backend, and data sharing platform.
• Enhance and maintain the Alnylam Data Sharing request process, facilitating Data Sharing request review and decision-making.
• Serve as subject matter expert for CTDT requirements and regulations. Maintain continuous knowledge of regulatory requirements, guidance, and industry trends related to clinical trial disclosure.
• Represent CTDT on project teams and/or CTDT collaborative initiatives.
• Collaborate effectively with all stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Clinical Research, Medical Affairs, Safety, Quality, Corporate Communications, and Data Sciences as well as with external stakeholders, bringing specialized knowledge of global disclosure requirements and standards to study teams, providing guidance on best practices.
• Contribute to or have ownership of the development of training manuals, working instructions or standard operating procedures (SOPs)
• Support or lead process improvement initiatives for CTDT as required.
• Oversee interns, contractors, or training of more junior CTDT team members.

Qualifications:

• Bachelor's degree in Life Science.  Advanced degree and/or professional certification/credentials preferred.
• 6+ years of experience in Clinical Trial Disclosure and Transparency in the sponsor and/or CRO setting. 
• Expert understanding of global regulatory requirements for clinical trial disclosure.
• Superior working knowledge and familiarity with ClinicalTrials.gov and EudraCT/EU CTR
• Detail-oriented with excellent interpersonal and communication skills
• Strong ability to work both independently and with a team in a global cross-cultural environment.
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Excellent communication skills and ability to deliver clear messages to varied audiences.
• Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner.
• Must be proficient with Microsoft Windows, Word, Excel, Power Point, and other Office applications.

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