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Manager Clinical Trial

Daiichi-Sankyo
4+ years
Not Disclosed
15 June 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Clinical Trial Information Disclosure Manager


Employer: Daiichi Sankyo, Inc.
Location: Basking Ridge, New Jersey (NJ), United States
Job Type: Full Time
Job Code: J3N6TY6BMST4DQ30T6N
Category: Regulatory Affairs
Post Date: 06/07/2024


Description:

Join Daiichi Sankyo, a global pharmaceutical leader dedicated to delivering innovative therapies and improving healthcare worldwide. As a Clinical Trial Information Disclosure Manager, you will play a pivotal role in ensuring compliance with global disclosure regulations and principles, contributing to our mission of addressing unmet medical needs.

Summary:

The Clinical Trial Information Disclosure Manager oversees company operational activities to adhere to US, EU, Japan, and other regional disclosure regulations, as well as international principles. As a member of the Global Clinical Trial Disclosure Platform and Operations Committee, you will lead initiatives to ensure compliance with current requirements and contribute to strategic planning for future changes.

Responsibilities:

  • Coordinate company initiatives to comply with global trial disclosure regulations and principles.
  • Act as a subject matter expert on clinical trial registration, result posting, plain language summary, redaction/anonymization, and data sharing requirements.
  • Monitor and assess regulatory requirements, develop compliant processes, and provide guidance to project teams.
  • Build strong relationships with key stakeholders across functions and foster awareness of clinical trial information disclosure.
  • Provide oversight for trial disclosure processes and manage vendors and CROs.
  • Communicate internal compliance metrics and act as the lead Data Sharing Coordinator.
  • Lead or co-lead global process development and procedural document drafting.
  • Ensure timely responses to queries and review requests for clinical trial data.
  • Draft agendas, minutes, and lead actions for trial disclosure-related meetings.

Qualifications:

  • Education:

    • Bachelor's Degree in pharmacy, biology, chemistry, medicine, or equivalent required.
    • Master's of Science Degree preferred.
  • Experience:

    • 4 or more years of experience with a Bachelor's Degree in the pharmaceutical industry, with clinical trial information disclosure experience highly desirable.
    • 1 or more years of experience with a Master's of Science degree.
    • Working knowledge of global laws, regulations, and guidelines related to clinical trial documents and data disclosure preferred.
    • General knowledge of global pharmaceutical legislation preferred.

Travel: Ability to travel up to 10%, including international travel for workshops, interactions with external regulators, industry bodies, and stakeholders.


Note: Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.

Please ensure you apply to the job posting no later than the day BEFORE the job posting end date.