Maxis Clinical Sciences - Country Manager - Clinical Operations - Global Pharma Giant

Job role:

- To enable organisations 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 businessof 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 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, 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.

- Always ensures audit and inspection-readiness 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

Qualifications :

- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.

- Experience : 15-20 Years

- 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.