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Summary
The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan and other regional disclosure regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction and data sharing requirements.
Responsibilities
- Coordinating company initiatives, strategies and operational activities to comply with the US, EU, Japan and other regional trial disclosure regulations and the IFPMA and EFPIA-PhRMA principles, including implementation of EMA Policy 0070 (and other external policies) and its subsequent compliance.
- Subject matter expert on global clinical trial registration, summary result posting, plain language summary, redaction/anonymization and data sharing requirements.
- Monitors assesses these requirements, creates compliant processes and provides advice to project functional teams, as needed. Proactively identifies and manages risks.
- Builds close working relationships with key company stakeholders across functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group members.
- Training raises awareness of the topic of clinical trial information disclosure within the company globally. Designs and implements programs to deliver sustainable learning.
- Provides oversight for the end-to-end processes across the trial disclosure area.
- Manages vendors and CROs providing trial disclosure services to Daiichi Sankyo.
- Effectively communicates internal compliance metrics within Daiichi Sankyo.
- Member of Global Clinical Trial Disclosure Function and Operations Committee.
- Act as the lead Data Sharing Coordinator from external sources and internal SMEs.
- Ensure prompt responses to queries for information or documents from external sources.
- Ensure prompt and thorough review of requests for de-identified company clinical trial data.
- Ensure company clinical trial data on the Vivli data sharing and research portal is current.
- Lead/co-lead global process development and procedural document drafting, as appropriate.
- If necessary, substitutes for the Director at trial disclosure related meetings.
- Drafting agendas and minutes, leading actions as appropriate and ensuring deliverables are completed on time and within budget.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree (State Examination, Diploma) pharmacy, biology, chemistry, medicine, or equivalent required
Experience Qualifications
- 4 or More Years Experience in the pharmaceutical industry and in the area of clinical trial information disclosure highly desirable
- 1 or More Years of experience with a Master’s of Science degree
- Working knowledge of key global laws, regulations and guidelines relating to clinical trial documents and data disclosure is desirable. preferred
- Good general knowledge of key global pharmaceutical legislation preferred
Travel Ability
- Travel up to 10% Standard office based physical demands, and some international travel for internal and external workshops / interactions with external regulators, industry bodies and key stakeholders. Ability to travel within US, and to the EU & Japan.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
