Clinical Operations Director
il y a 3 semaines
About this role
Parexel is seeking a skilled Clinical Operations Leader to join our team in France. As a Local Study Associate Director, you will be responsible for supporting studies within your country or region, adhering to our mantra of 'manageable sites, manageable protocols.'
Key responsibilities
- Deliver committed components of clinical studies according to agreed resources, budget, and timelines, complying with Client Procedural Documents, international guidelines, and relevant local regulations.
- Lead and optimize the performance of the Local Study Team(s) at country level, ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
- Ensure 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.
- Ensure 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.
About Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today's top 50 best-selling drugs, but equally, we enable more niche drug developments that are critical to the well-being of many patients.
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