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Abbvie - Country Clinical Operations Manager

Abbvie - Country Clinical Operations Manager

Abbvie IndiaBangalore, India
8 hours ago
Job description
  • To enable AbbVie's emergence as a world class R&D organization, the Site Management and Monitoring (SMM) Country / District COM plays a leadership role accountable for driving the business of SMM within a Country / District(s) by providing oversight and direction to SMM staff; accountable for the on time, within budget and quality delivery of the clinical studies.
  • Promotes best practice; identifies infrastructural improvements and implements action plan to ensure Clinical Field Operations (CFO) and business objectives are successfully met; ensures alignment of local activities with regional / global initiatives.
  • The role reports into the Site M&M Leadership and serves as a single point of accountability for the SMM deliverables within a Country / Disitrct(s) and influences and aligns within Development Operations, and with Global Medical Affairs (GMA), and other key stakeholders across the :
  • Manages / oversees site / country or district related activities as they relate to AbbVie clinical studies (e. country feasibility, site evaluation / selection and activation, contracts / budget negotiation, regulatory / EC submissions startup, issue management, relationship management, monitoring, site closure).
  • Accountable for the on-time and within budget execution of all clinical trials within Provide local regulatory and legal requirement expertise.
  • Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
  • Monitor regulatory reforms and industry trends within country / region.
  • Conduct and / or implement impact analysis of all significant changes to conform with updated regulatory / industry regulations affecting conduct of clinical studies.
  • Ensures audit and inspection-readiness at all times.
  • Country contact for regulatory agency questions related to monitoring processes and procedures.
  • Drive CAPA preparation and implementation.
  • Accountable for managing country / district resources including need identification, timely hiring and allocation, and managing changes to hiring plan.
  • Responsible for staff recruitment and retention plans.
  • Accountable for functional budget planning and administration.
  • Provide leadership to the Country / District and be accountable for growth and development of a world class workforce that role models AbbVie behaviors.
  • Drives a learning environment and ensures continuous improvement in Country / District(s) performance by using innovative approaches, active analysis of Key Performance Indicators, metrics and milestones.
  • Driving simplicity in process and approach, and enhancing agility.
  • Accountable for ensuring SITE M&M leadership, collaboration and teamwork across all key stakeholders within the Country(s).
  • May lead global Task Forces and Initiatives.
  • Interacts with peers within the industry to stay abreast of regulatory landscape, raise AbbVie' s profile in the R&D community. Accountable for driving affiliate R&D Community goals in partnership with GMA.

    • Qualifications :

    Education : Bachelors or equivalent degree, health related (e. Medical, Scientific, Nursing, Pharmacy) preferred.

    • Site Monitoring Experience : Minimum 3 years.
    • Preferably having monitored and / or managed a study within a Country from start to close.
    • Experience in functional budget planning, resource planning & assignment, quality management in a Country lead capacity preferred.
    • At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred.
    • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
    • Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
    • Experience across multiple Therapeutic Areas and Study Phases.
    • Demonstrating business ethics and integrity.

      • (ref : iimjobs.com)

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