Job Description

CORE JOB RESPONSIBILITIES:

To enable The Client'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 The Client 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 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, The Client 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 The Client 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 The Client' s profile in the R&D community. Accountable for driving affiliate R&D Community goals in partnership with GMA

PREFERRED 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