Associate Clinical Operations Manager (m/w)
AbbVie (NYSE:ABBV) ist ein globales, forschungsbasiertes Biopharmaunternehmen, welches 2013 im Zuge der Separation von Abbott Laboratories entstand. Unsere Mission ist es die bestehende Expertise, die Leidenschaft unserer Mitarbeiter und einzigartige innovative Ansätze zu nutzen um neuartige Therapien für einige der weltweit komplexesten und schwersten Krankheiten zu entwickeln und verfügbar zu machen. Mit circa 30.000 Mitarbeitern weltweit vertreibt AbbVie Medikamente in mehr als 170 Länder.
To enable AbbVie’ s emergence as a world class R&D organization, the position is accountable for all activities of site related study execution directly or by leadership of assigned CRAs involving startup,execution, and closeout.
- Accountable for the on time and within budget study execution of assigned projects, including but not limiting to country and site feasibility.
- Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. 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. May monitor regulatory reforms and industry trends within country / district, 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.
- Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
- Responsible for the acquisition and retention, performance management, and growth and development of talent.
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Site Monitoring Experience: Minimum 3 years.
- 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) projects with competing deadlines. Experience across multiple Therapeutic Areas and Study Phases.
- Drives continuous improvement and simplicity in process and approach and enhances agility.
- Demonstrated business ethics and integrity.
- Fluent in both, German and English.
We are looking forward for your application. Please give us 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.