Country Clinical Operations Manager
- Strategic Leader of country Clinical Site Management team, including country startup specialists, accountable for growth and development of a world class team that role models AbbVie behaviors
- Cross-functional engagements with stakeholders across all key functions within the Country, including; Medical Affairs, HR, Finance, General manager and with area / global study teams.
- Managing /overseeing country related activities as they relate to AbbVie clinical studies (e.g. country feasibility, site evaluation/selection and activation, regulatory/EC submissions startup, issue management, relationship management, monitoring). Accountable for the on-time and within budget execution of all clinical trials within a Country.
- Provide local regulatory and legal requirement expertise to study teams where required
- Ensure adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research.
- Monitor regulatory reforms and industry trends within country. 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 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.
- Drives a learning environment and ensures continuous improvement in Country performance by using innovative approaches, active analysis of Key Performance Indicators, metrics and milestones.
- Driving simplicity in process and approach, and enhancing agility.
- 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 Global Medical Affairs.
At AbbVie, we believe the paths we take to achieve our breakthroughs matter. That how we get there is just as vital as the outcome. We get there together—all of us asking bold questions and finding new answers. Being flexible in the ways we grow and learn. And strengthening our culture built on deep, honest collaboration. For those who honor small wins and push past wrong turns, for anyone who thrives taking on the tough challenges with a diverse team: we’re ready for you.
Great Place To Work
AbbVie has been at the top of the global 'Best Workplaces' list in the Netherlands, Europe and worldwide for several years in a row. We are proud of this! This recognition by Great Place to Work is reflecting employee experiences of trust, innovation, company values and leadership, across Europe. It is an acknowledgement of being a fulfilling workplace, a recognition of our culture and the result of the ways we work together.
- 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.
- Preferred 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.
- Dutch preferred
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.