For our German Affiliate in Wiesbaden (home office partly possible) we are searching for a
Clinical Operations Manager (all genders)
- As people leader, responsible for the line management, recruitment, retention, performance management, growth, and development of talent (CRAs, Study-Start-Up Specialists and CPAs)
- Accountable for all activities of in-country site related study execution oversight of a therapeutic area or assigned studies involving start-up, study execution, and close-out
- 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 start-up, issue management, relationship management, site engagement, 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.
- Ensure audit and inspection readiness of assigned sites through quality control measures. Advise on pre-audit activities for GCP requirements. Prepare and follow-up site and system audits, CAPA preparation and implementation.
- 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.
- Identifying training needs and standardizing and facilitating training solutions for the team. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
- Independently serve as key point of contact in country for a therapeutic area or different studies with higher level complexity. Country level planning timelines, act as local study representative where needed
- Collaborating with key stakeholders to achieve proactive, strategic, and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
- Act as SME and contribute to various global initiatives to optimize study execution
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
- Preferably 5 years Site Monitoring Experience
- 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 leader and 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 German and English skills
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.
Travel: Yes, 5 % of the Time
Job Type: Experienced