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Country Clinical Operations Manager Germany (m/w)

Naturwissenschaften, TA - Biotechnologie, Pharma - Unbefristet - Vollzeit

Country Clinical Operations Manager Germany (m/w)

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 organization.

  • Manages/oversees site/country or district related activities as they relate to AbbVie clinical studies (e.g. 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 a Country/District(s). 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 inspectionreadiness 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.
  • Education: Bachelors or equivalent degree, health related (e.g. 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. Demonstrated proactive and positive team
    player.
  • Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with
    experience leading (within country or region) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.
  • Demonstrating business ethics and integrity.

 We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.

Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we're active.

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AbbVie Deutschland GmbH & Co. KG
Mainzer Straße 81
D-65189 Wiesbaden
www.abbvie.com

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