Country Clinical Operations Manager Germany (all genders)

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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.

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.

·        Experience in functional budget planning, resource planning & and 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.

Here's how we can move mountains together:

·        with a diverse work environment where you can have a real impact

·        with an open corporate culture

·        with an attractive salary

·        with an intensive onboarding process with a mentor at your side

·        with flexible work models for a healthy work-life balance

·        with a corporate health management that offers comprehensive health and exercise programs

·        with company social benefits

·        with a wide range of career opportunities in an international organization

·        with top-tier, attractive development opportunities

·        with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email as at olga.zhikhareva@abbvie.com – we look forward to hearing from you!

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.