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    Manager, Data Management Leader

    Johnson & Johnson
    5+ years
    Not Disclosed
    Mumbai
    10 July 26, 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 Title: Manager, Data Management Leader
    Location: Mumbai, Maharashtra, India
    Function: Data Analytics & Computational Sciences
    Sub-Function: Clinical Data Management
    Category: Manager, Clinical Data Management (P7)
    Date Posted: July 23, 2024
    Requisition Number: 2406201553W

    Description

    As the Data Management Leader (DML) – Senior Manager within the Integrated Data Analytics and Reporting (IDAR) organization, you will play a pivotal role in shaping the data management strategy for programs of low to medium complexity across various therapeutic areas or regions. You will oversee the planning, execution, and management of all data management activities for multiple clinical trials within your assigned programs or regions.

    In this role, you will supervise Global Data Managers (GDM), managing their hiring, onboarding, coaching, and performance evaluations. You will also handle flex staff assignments and assess their effectiveness. As the primary contact for the Global Program Leader (GPL), you will be responsible for addressing data management issues and proposing solutions to the Functional Lead (FL), GPL, and IDAR Therapeutic Area Lead (TAL) as needed.

    Principal Responsibilities:

    • Strategic Planning and Execution: Develop and oversee data management strategies for assigned programs/regions. Ensure timely, budget-compliant, and high-quality execution of all data management activities.
    • Primary Contact: Act as the main point of contact for data management with the GPL. Define data management strategies, including selecting external service providers, in collaboration with IDAR TAL and TA FL.
    • Vendor Management: Contribute to vendor contract development and R&D budget estimates. Evaluate resource needs and update functional planning systems accordingly.
    • Issue Resolution: Anticipate, prevent, and address issues impacting data management deliverables. Manage issue resolution and escalate as needed.
    • Collaboration: Work with IDAR staff and vendors to ensure milestone delivery. Define data integration strategies with internal and external partners. Lead data management aspects of regulatory inspections and internal audits.
    • Leadership: Lead data management team meetings, attract and retain top talent, and provide performance management, career development, and salary administration for direct reports.
    • Policy Development: Contribute to the development and maintenance of departmental policies, procedures, and standards. May serve as a process, standard, or system owner.

    Principal Relationships:

    • Internal Contacts: Functional Lead, Global Data Managers, Clinical Data Acquisition Expert Leads, Statistical Programming Leaders, Clinical Data Standards, Risk Management Central Monitoring Leads, Regulatory Medical Writing Leads, IDAR TAL.
    • External Contacts: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Regulatory, Clinical Project Management Leads, External Alliances, Human Resources, and Project Coordinators.

    Qualifications:

    • Education: Bachelor’s/Master’s degree in a scientific discipline required; PhD with post-doctoral experience also considered.
    • Experience: 5+ years of relevant experience with a Bachelor’s/Master’s degree or 3+ years with a PhD. In-depth knowledge of data management practices, regulatory guidelines, and therapeutic area experience required.
    • Skills: Project management experience, including customer interaction, team leadership, outsourcing strategies, contract oversight, and negotiations. Strong communication skills and experience in a matrix environment are essential. Proven leadership, decision-making skills, and the ability to adapt to a rapidly changing environment are required.
    • Knowledge: Expertise in regulatory guidance documents such as GCP/ICH and relevant clinical R&D concepts. Experience supervising staff preferred.

    Equal Opportunity Employer

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. We evaluate all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and do not discriminate based on disability.

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