Provides oversight of contract workers (CRAs, CTC) and works closely with external vendors, site investigators.
Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. List the work-related aspects of the position (complete for every position)
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Client’s reputation. In collaboration with CRD, represents Client in Pharma industry issues and in seeking influence in external R&D environment.
PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. 20%
EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.20%
INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.10%
Masters in Science (or comparable)
Advanced degree (MD, PhD) possible but not required.
8-10 years of experience for a MS/MBA/JD;
3-6 years for an MD-PhD
Strong leadership skills
Knowledge in Site Management
Strong organizational skills
Strong organizational skills with demonstrated success required.