AbbVie Country Clinical Operations Manager in Warsaw, Poland
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
Employment under a replacement contract.
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 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.
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.
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.