- 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.

Responsibilities :

- Manages/oversees site/country or district related activities as they relate to AbbVie clinical studies (e. 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 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 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/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. 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.

- Experience across multiple Therapeutic Areas and Study Phases.

- Demonstrating business ethics and integrity.