Local Study Associate Director

October 11

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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+

💰 Venture Round on 1990-01

Description

• Dedicated to one client. • Responsible 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. • Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports. • Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations. • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.

Requirements

• Minimum of 3 years' experience running local clinical trials. • 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. • Experience in, and willingness to monitor oncology clinical trials - if needed based on flexible capacity. • Experience performing submissions to RA and EC • Experience partnering with study functions to ensure smooth delivery. • Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.