Local Study Associate Director

November 20

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. • The LSAD may perform site monitoring as needed to support the flexible capacity model. • The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. • Ensures timely delivery of data to required quality. • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies. • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction). • Provides input to process development and improvement. • Ensures compliance with Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Requirements

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies). • Good knowledge of international guidelines ICH GCP as well as relevant local regulations. • Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality. • Excellent project management skills. • Excellent team building and interpersonal skills. • Excellent organizational skills. • Excellent verbal and written communication skills. • Excellent ability to prioritize and handle multiple tasks. • Excellent attention to detail. • Proficient in written and spoken English language required. • Fluency in local language(s) required. • Good negotiation skills. • Good analytical skills. • Good resource management skills. • Good decision making and delegation skills. • Good financial management skills. • Basic change management skills. • Basic coaching skills. • Basic ability in handling crisis situations. • Knowledge and Experience (Desirable) : Good medical knowledge and ability to learn relevant Client Therapeutic Areas. • Good knowledge of the Drug Development Process. • Excellent understanding of the Clinical Study Process including monitoring. • Very good understanding of the Study Drug Handling Process and the Data Management Process. • Good intercultural awareness.