Senior Clinical Operations Manager

Senior Clinical Operations Manager

AbbVie

Baar, Switzerland

To enable AbbVie’ s emergence as a world class R&D organization, the Senior Clinical Operations Manager for Switzerland is leading the Site Management and Monitoring team accountable for all activities of site-related study aspects including start-up, execution, and close-out in the country. This position is reporting into the DACH Site Management and Monitoring Manager.

With the goal of delivering studies on time, with quality and on budget, the Senior Clinical Operations Manager is an expert on the global, regional and local Clinical Research regulations and practices, and acts as the main PoC at local level for internal and external stakeholders.

Main Tasks/Responsibilities:

  • Accountable for all activities of site related study execution of assigned studies/staff involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including country and site feasibility. 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. Stay abreast of new and/or evolving local regulations, guidelines and policies. Monitor regulatory reforms and industry trends within country and provide impact analysis of significant changes affecting conduct of Clinical studies;
  • Ensure audit and inspection readiness of assigned sites. Advise on preaudit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation. Conduct trending, impact analysis and implement actions within country;
  • Responsible for resource management of the country in collaboration with manager. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identifies and communicates issues impacting resource allocation and provides solutions;
  • Responsible for budget planning & oversight of expenses across country;
  • Responsible for the acquisition, retention, performance management, growth and development of talent in the Site Management and Monitoring team.

Qualifications:

  • Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred;
  • Minimum 2 years of direct line management experience including acquisition, retention, performance management, growth and development of staff, coordinating, coaching and mentoring the team;
  • Minimum 5 years of experience in Clinical Research, preferably in different TAs and study phases, managing study feasibility, site selection, study initiation, site monitoring/study management from start to close;
  • Deep knowledge of all International and Local regulations which apply to all Clinical Research activities globally, regionally and locally;
  • Previous experience in functional budget planning, resource planning & assignment, quality management;
  • 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;
  • Adaptability to changing requirements and flexibility to manage competing priorities;
  • Creative, pro-active and positive team player eager to work cross-functionally in an international environment;
  • Strong planning and organizational skills;
  • Drives continuous improvement and simplicity in process and enhances agility;
  • Demonstrated business ethics and integrity;
  • English and German proficiency.

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© EuroJobsites 2021

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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