Country Clinical Operations Manager
Location: Bangalore, Karnataka, India
Function: Research & Development
Employment Type: Full-Time
Experience Required: 6–10 years in Clinical Operations / Site Management & Monitoring
Job ID: R00132974
Company Overview
AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative therapies that address complex health challenges. With a strong presence across immunology, oncology, neuroscience, eye care, and aesthetics, AbbVie continues to advance clinical research and improve patient outcomes worldwide. Learn more at www.abbvie.com.
Role Summary
AbbVie is seeking an experienced Country Clinical Operations Manager (COM) to provide strategic and operational leadership for Site Management and Monitoring (SMM) activities within India. This role is accountable for end-to-end delivery of clinical studies, ensuring timelines, quality, regulatory compliance, and budget objectives are met. The position serves as the single point of accountability for SMM execution at the country level and works closely with Development Operations, Global Medical Affairs, and cross-functional stakeholders.
Key Responsibilities
Clinical Operations Leadership:
Lead and oversee all country-level clinical trial activities, including feasibility, site selection, activation, monitoring, issue management, and site close-out.
Ensure on-time, within-budget, and high-quality execution of all clinical studies across assigned country or districts.
Provide expertise on local regulatory, legal, and operational requirements impacting clinical trials.
Regulatory Compliance & Quality:
Ensure full compliance with ICH-GCP, local regulations, AbbVie SOPs, and monitoring plans.
Maintain continuous audit and inspection readiness and act as the country contact for regulatory agency inquiries.
Drive CAPA development and implementation following audits or inspections.
Monitor regulatory reforms and industry trends and assess their impact on ongoing and future studies.
People & Resource Management:
Lead country-level workforce planning, hiring, deployment, and retention strategies.
Provide line management, coaching, performance management, and professional development for SMM staff.
Foster a high-performance, compliant, and learning-driven clinical operations team.
Operational Excellence & Strategy:
Own country-level functional budget planning and financial oversight.
Track KPIs, metrics, and milestones to drive continuous improvement and operational efficiency.
Promote process simplification, agility, and best practices across clinical field operations.
Collaborate with regional and global teams to align country activities with enterprise R&D strategies.
Stakeholder Engagement:
Build strong collaboration with internal stakeholders including Global Medical Affairs, Quality, Regulatory, and Development Operations.
Represent AbbVie in industry forums and contribute to global task forces and R&D initiatives as required.
Qualifications & Experience
Education:
Bachelor’s degree or equivalent in a health-related discipline such as Medicine, Life Sciences, Pharmacy, Nursing, or Clinical Research.
Experience:
Minimum 6–10 years of experience in Clinical Operations or Site Management & Monitoring.
At least 3 years of hands-on site monitoring experience, including managing studies from start-up to close-out.
Minimum 2 years of people management experience, including hiring, performance management, coaching, and talent development.
Experience in budget planning, resource management, and quality oversight at a country or regional level preferred.
Key Skills:
Strong knowledge of ICH-GCP, clinical trial regulations, and inspection readiness.
Excellent analytical, decision-making, and problem-solving capabilities.
Proven leadership, stakeholder management, and cross-functional collaboration skills.
Ability to manage complex projects across multiple therapeutic areas and study phases.
High ethical standards, integrity, and commitment to regulatory compliance.
Why Join AbbVie
AbbVie offers the opportunity to lead high-impact clinical research programs in a globally respected organization. You will play a critical role in shaping clinical operations strategy, developing teams, and advancing innovative therapies in a collaborative and inclusive environment.
AbbVie is an equal opportunity employer, committed to ethical conduct, innovation, and regulatory excellence.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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