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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Research & Development
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1901902 Requisition #
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Abbvie is looking for a Country Clinical Operations Manager

 

AbbVie is a research biopharma company that develops innovative treatments and sustainable care solutions for severe diseases, with the goal of improving the lives of people affected by disease. Our focus areas are immunology, neurology, oncology and virology. AbbVie is located in 170 countries and has approximately 29,000 employees. In Sweden, we have about 140 employees and headquarters in Solna.

 

A workplace for personal growth.

Since AbbVie was formed, there has been a clear conviction that the most important asset and greatest competitive advantage is our employees. Our workplace is characterized by commitment, openness and trust in each individual's ability. We want to create an exploratory environment where everyone can achieve their full potential.

 

Our goal is to become Sweden's best workplace, and we participate annually in Great Place to Work. In 2018, AbbVie was named Sweden's third best workplace.

 

We encourage our employees to participate in our company intiatives regarding voluntary work. Therefore we have long term collaborations with several selected organizations. We offer benefits such as healthcare, health benefits, massage at work and many more.

Primary objectives for a Country Clinical Operations Manager at Abbvie

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

 

Major responsibilities

·   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 on­time 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 inspection­readiness 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.


Qualifications

·   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.

 

Practical information

We are recruiting a full time job located in Solna. You will be travelling approximately 10% of your time and mainly within Europe . 

 

Please send in your application as soon as possible as we will interview on an ongoing basis. Personal qualities and match against our culture are extremely important to us and therefore this will have a great impact in our selection.

 

We look forward to your application!

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