Country Clinical Operations Manager Germany in Wiesbaden bei ABBVIE

Country Clinical Operations Manager Germany (all genders) in Wiesbaden bei ABBVIE

ABBVIE

What makes you stand out, makes you ready to make an impact. At AbbVie

Science is at the heart of what we do. People are at the heart of why we do it.

Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place!

In our Clinical, Site Management and Monitoring department within Research and Development, you will be working in a team of talented people and experienced experts toward developing tomorrow's products. In cutting-edge laboratories, you will be setting highest standards in the competitive field.

Moving mountains together –

as Country Clinical Operations Manager Germany (all genders) in Wiesbaden

To enable AbbVie’s emergence as a world class R&D organization, the Clinical Site Management Country- COM - Germany plays a leadership role accountable for driving the business of CSM within Germany by providing oversight and direction to CSM staff; accountable for the on time, within budget and quality delivery of the clinical studies within Germany. Promotes best practices; identifies infrastructural improvements and implements action plan to ensure functional and business objectives are successfully met; ensures alignment of local activities with regional/global initiatives. The role reports into the Region Head, Clinical Site Management Europe Central and serves as a single point of accountability for the CSM deliverables within Germany and influences and aligns within Development Operations CDO, Clinical Study Leadership (CSL), Global Study-Start-Up and with Global Medical Affairs (GMA), and other key stakeholders across the organization.

Make your mark:

Manages/oversees country related activities as they relate to AbbVie interventional 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 Germany. 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 the 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, staff development and retention plans.

Accountable for functional budget planning and administration.

Provide leadership to Clinical Operations Managers (COM) 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 Germany’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 CSM leadership, collaboration and teamwork across all key stakeholders, taking leadership also to support CDO staff based in Germany in general.

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 sciences related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Graduate degree preferred.

Site Monitoring Experience: Minimum 3 years having monitored and/or managed a study within a Country from start to close. Experience with Germany highly desired.