Global Study Director

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TFS HealthScience

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Clinical Research Excellence

CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting

501 - 1000

Description

• Accountable from set-up through maintenance, close-out and study archiving for the operational planning, leadership and delivery of multiple studies • Contributes expert clinical operational input into project strategy and study design/or documents • May perform Study Management department leadership tasks as delegated by the Senior Director Study Management • Lead and facilitate communication across all functions • Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams

Requirements

• University degree (or equivalent educational/work experience), preferably in medical or biological sciences • Minimum of 7 years progressive experience in clinical research, with at least 5 years of clinical development project management experience • Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development • Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs • Extensive and proven experience project management and in driving operational delivery to timelines, cost and quality

Benefits

• Competitive compensation package • Comprehensive benefits • Opportunities for personal and professional growth