Country Manager Clinical Ops For a 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 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

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.

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Puja Khemchandani