Career Category

Job Description

Job Purpose

• Develop and maintain the local landscape knowledge in line with the Global Development pipeline to support strategic global study design and excellence in clinical trial delivery

Responsibilities:

• Management of indication and study operational landscaping at a country level
• Inform stakeholders on country capability
• Provide local input into study risk identification and mitigation
• Drive Targeted local feasibility
• Set up local country commitments and timelines
• Develop Country Operational Plan
• Drive Voice of Patient and Voice of Site data collection, as applicable
• Drive local patient recruitment and retention strategies
• Take on DFM Point of Contact (PoC) role to coordinate and support Country Operational Landscaping Assessment (COLA) execution and analysis across the countries

Key Activities:

• Develop and maintain knowledge of external local clinical trial environment and assess impact on study design and execution
• Develop and maintain repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
• Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas
• Understand patient flows and referral pathways in support of global/local operational delivery
• Partner with study teams to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
• Select the sites (support selection for sites in Early Development studies) within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process.
• Identify and contract Reference Sites in support of local landscaping
• Engage with local reference sites in collaboration with local medical team to obtain input on proposed study design (Study Design Optimization) and partner with study team representatives to analyse local feedback for incorporation into study design and operational planning decisions
• Support operating reviews by analyzing COLA participation and outcomes, predictability and delivery
• Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification
• Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager Forum
• Act, on request, as DFM – POC, coordinating and analyzing the COLA outputs and sharing these with GCPM

Basic Qualifications

• Bachelor’s degree in related field
• Experience of working in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred Qualifications              

• Masters Degree, M.D., Pharmacy
• Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Clinical trial management experience
• Operational performance measurement experience
• International collaboration experience

Knowledge

• Knowledge of local country and international clinical trial management (including regulations & guidelines)

**DFM will be hired as a “Contractor” for indefinite period.