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    Country Clinical Operations Manager

    Abbvie
    3+ years
    Not Disclosed
    Bengaluru
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    The Country Lead at AbbVie is responsible for overseeing and managing the clinical study activities within a designated country or district. This includes ensuring the timely and within-budget execution of clinical trials, adhering to regulatory requirements, and managing relationships with key stakeholders.

    Key Responsibilities:

    1. Clinical Study Management:

      • Oversee all aspects of clinical trials, including site feasibility, evaluation, activation, contracts, regulatory submissions, and issue management.
      • Ensure compliance with federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs).
      • Ensure audit and inspection-readiness at all times and lead Corrective and Preventive Action (CAPA) preparations and implementation.

    2. Leadership & Team Development:

      • Provide leadership to the Country/District team, ensuring growth and development of a high-performing workforce.
      • Manage staffing needs, recruitment, and retention strategies.
      • Develop and implement strategies to drive continuous improvement in team performance and ensure high-quality output.

    3. Budget & Resource Management:

      • Oversee functional budget planning and administration for clinical studies within the country/district.
      • Manage country/district resources, ensuring effective allocation and timely hiring based on study needs.

    4. Collaboration & Stakeholder Management:

      • Ensure effective collaboration and teamwork across all stakeholders involved in clinical studies.
      • Lead global task forces or initiatives, staying informed of regulatory trends and industry standards.
      • Drive affiliate R&D goals in partnership with Global Medical Affairs (GMA) and other internal teams.

    5. Regulatory Compliance & Risk Management:

      • Monitor regulatory reforms and industry trends and implement necessary changes to comply with new regulations.
      • Act as the country contact for regulatory agency questions related to monitoring processes and procedures.

    Qualifications:

    • Education: Bachelor's degree (or equivalent) in a health-related field such as Medical, Scientific, Nursing, or Pharmacy.

    • Experience:

      • Minimum 3 years of site monitoring experience, with preference given to candidates who have managed studies from start to close.
      • Experience in functional budget planning, resource management, and quality management in a country lead capacity is preferred.
      • At least 2 years of experience in line management, including talent acquisition, performance management, coaching, and staff development.
      • Experience across multiple therapeutic areas and study phases is a plus.

    • Skills:

      • Strong analytical, critical thinking, and decision-making abilities.
      • Excellent interpersonal communication skills with the ability to adapt to changing requirements and manage competing deadlines.
      • Strong planning, organizational, and leadership skills in a dynamic environment.
      • High ethical standards and commitment to compliance with AbbVie’s values and Code of Conduct.

    Additional Information:

    • Equal Opportunity Employer: AbbVie is committed to diversity and inclusion, offering equal opportunities for all applicants, regardless of race, religion, gender, disability, and other protected statuses.
    • Ethical Standards: The company places a strong emphasis on maintaining high ethical standards in all its business dealings, both internally and externally.

    This role is ideal for experienced professionals in clinical research management who are skilled in overseeing clinical trials, managing teams, and ensuring compliance with regulatory standards.

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