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Manager, Clinical Trial Disclosure Group (CTDG)

5.00 to 10.00 Years   Mumbai City   27 May, 2023
PFIZER LIMITED
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    locations India - Mumbai India - Chennai time type Full time posted on Posted 5 Days Ago job requisition id hidden_mobile ROLE SUMMARYThe Manager within the Clinical Trial Disclosure Group (CTDG), under Global Data Dissemination and Transparency (GDDT), will be responsible for operational execution and oversight for all processes related to supporting Pfizer s public disclosure of study information and study results commitments on ClinicalTrials.gov, EudraCT, and Pfizer.com.The Manager will partner closely with Pfizer study teams in clinical, medical, legal, statistics and external business partners to ensure registrations and results postings adhere to internal policy and meet the requirements of public registry websites. This role will conduct quality reviews of disclosure deliverables and assist in gathering metrics for drug programs within their remit.The Manager will take the lead on projects related to applying health literacy principles to information posted publicly about Pfizer Sponsored studies.The successful candidate excels in project managing and influencing cross-functional and virtual teams in a fast-paced environment with aggressive deadlines in a continually evolving transparency landscape.ROLE RESPONSIBILITIES
    • Oversee operational execution for disclosure for products within remit, including but not limited to, registering clinical trial information and posting study results on ClinicalTrials.gov, EudraCT, and Pfizer.com.
    • Clinical Trial Disclosure SME and liaison to study teams in communicating Pfizer disclosure policies, processes, and system requirements to ensure compliance.
    • Utilizes internal and external systems and input from study teams for all disclosure related activities, including project management, authoring, reporting, and tracking.
    • Provides metrics and other compliance related information to senior leadership related to the products and/or studies within their remit.
    • Collaborates with CTDG team members to ensure consistency and management of best practices.
    BASIC QUALIFICATIONS
    • Bachelor s Degree or Pharm D or equivalent
    • 5-10 years relevant experience in the pharmaceutical industry or related field.
    • Professional experience in a clinical trial disclosure and/or clinical trial management.
    • User experience with Disclose system, also known as PharmaCM (PCM) and/or ClinicalTrials.gov Protocol Registration and Results System (PRS).
    • Proficiency with Microsoft Office 365 and other similar enterprise solutions.
    PREFERRED QUALIFICATIONS
    • Master s Degree preferred, but not required.
    • Health Literacy Certification or equivalent.
    • Professional experience in a quality assurance, pharmacovigilance, or regulatory role.
    • Understanding the legal/regulatory requirements and principles related to study and results transparency.
    • Ability to review and extract study design and analysis components of study protocols, statistical analysis plans, and clinical study reports.
    • Outstanding organizational, interpersonal and written/oral communication skills.
    • Ability to project manage in a fast-paced environment with aggressive deadlines.
    • Technologically savvy and flexible in learning new systems while detecting areas for continuous improvement.
    • Effectively lead and influence cross-functional and virtual teams.
    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical #LI-PFE,

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