Country Clinical Operations Manager, France

Country Clinical Operations Manager, France

AbbVie

Rungis, France

Purpose:

To enable AbbVie’s emergence as a world class R&D organization, the Site Management and Monitoring (SMM) Country COM plays a leadership role by being accountable for driving the business of SMM within the Country: providing oversight and direction to SMM staff, is accountable for delivery of the clinical studies run in the Country on time, with quality and within budget.

CCOM promotes best practice, identifies infrastructural improvements, implements action plans to ensure business objectives are successfully met and ensures alignment of local activities with regional/global initiatives.

The role reports into the Site M&M Leadership, serves as a single point of accountability for the SMM deliverables within the Country and influences and aligns within Development Operations, Global Medical Affairs (GMA) and other key stakeholders across the organization.

Responsibilities:

  • Manages/oversees site and country related activities for AbbVie clinical studies in the Country (e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation, regulatory/EC submissions startup, enrollment, issue management, relationship management, monitoring, site closure). Accountable for the on time and within budget execution of all clinical trials within the Country. Provides with local regulatory and legal requirement expertise.
  • Ensures 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. Monitors regulatory reforms and industry trends within country/region. Conducts and/or implements impact analysis of all significant changes to conform with updated regulatory/industry regulations affecting the conduct of clinical studies.
  • Ensures continuous audit and inspection readiness. Country contact for regulatory agency questions related to monitoring processes and procedures. Drives CAPA preparation and implementation.
  • Accountable for managing country resources including identifying needs, timely hiring and allocation, and managing changes to hiring plan. Responsible for staff recruitment, development and retention plans.
  • Accountable for functional budget planning and administration.
  • Provides leadership to the Country SMM staff and is 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 performance by using active analysis of Key Performance Indicators, metrics and milestones and proposing/driving innovative approaches. Drives simplicity in processes and enhances agility. Accountable for ensuring SM&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.

Education:

  • Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
  • English proficiency.

Experience:

  • At least 5 years of experience in line management of staff including acquisition of talent, performance management, growth and development of staff, managing employee relations, coaching and mentoring the team.
  • Experience in functional budget planning, resource planning & assignment, quality management in a Country lead capacity.
  • Working cross functionally in both local and international environments with demonstrated ability to influence.
  • Clinical Research Experience in Pharmaceutical company or CRO: > 8 years.
  • Managing study feasibility, site selection, study initiation, site monitoring/study management within the Country from start to close.
  • Deep knowledge of all International and Local regulations which apply to all Clinical Research activities globally, regionally and locally.
  • Experience across multiple Therapeutic Areas and Study Phases.

Skills:

  • 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 with experience leading projects with competing priorities.
  • Creative, proactive and positive team player.
  • Strong planning and organizational skills.
  • Demonstrating business ethics and integrity.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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