Senior Manager, Clinical Trial Transparency & Disclosure

Role Summary

Senior Manager, Clinical Trial Transparency & Disclosure is a high-impact role reporting directly to the Director of CTTD. Responsible for Plain language Summaries and other transparency and disclosure deliverables, from planning and coordination to final products. Acts as a crucial pivot in the clinical development team, influencing broader objectives of clinical development programs.

Responsibilities

• Functional Knowledge: Apply in-depth knowledge of transparency and disclosure within clinical development programs.
• Document Planning: Develop and manage strategic document plans for clinical and regulatory submissions.
• Project Management: Oversee timely progress of disclosure deliverables and meet deadlines.
• Cross-Functional Collaboration: Work with cross-functional teams to ensure alignment of clinical and regulatory documents.
• Regulatory Compliance: Ensure documents comply with regulatory, industry, and corporate guidelines and standards.
• Data Interpretation: Interpret and present clinical data and other complex information.
• Quality Control: Implement and oversee quality control processes for authoring and reviewing documents.
• Disclosure Updates: Regularly update study details on global registries to reflect current information and regulatory requirements.
• Problem Solving: Solve complex problems; exercise judgment based on analysis of multiple sources.
• Impact: Apply new perspectives on existing solutions and exercise judgment based on multiple information sources.
• Develop and Implement Departmental Strategies: Contribute to goals and objectives for the CTTD team aligned with company strategy.
• Line Management: Manage direct reports (if applicable).

Qualifications

• Education and Years of Experience: Advanced degree preferred with ~4 years of relevant experience, or bachelor‚Äôs degree with ~9 years of relevant experience.
• Industry Experience: Proven experience in plain language summaries for registration and results (Ct.gov; CTIS) and authoring disclosure documents for global authority submissions.
• Interpersonal Skills: Excellent interpersonal skills; ability to guide others internally or with vendors; ability to explain difficult information and build consensus.
• Leadership Skills: Ability to manage multiple supervised individuals; lead functional projects; mentor colleagues.
• Business Expertise: Knowledge of best practices and how CTTD integrates with the organization; awareness of competition and market differentiation.
• Communication Skills: Exceptional written and verbal communication; ability to convey complex scientific information clearly.
• Quality: Commitment to high-quality, accurate, and comprehensive work; strong attention to detail and multitasking ability.
• Technical Skills: Proficiency in Microsoft Office and familiarity with Disclosure software and tools.

Education

• Advanced degree preferred; or bachelor‚Äôs degree with substantial relevant experience as outlined above.