Clinical Operations Leader (LSAD) - Oncology Experience Required - UK - FSP
Parexel Uxbridge, England, United Kingdom
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Clinical Operations Leader (LSAD) - Oncology Experience Required - UK - FSP
Parexel Uxbridge, England, United Kingdom
2 days ago Be among the first 25 applicants
Join to apply for the Clinical Operations Leader (LSAD) - Oncology Experience Required - UK - FSP role at Parexel
Parexel is currently seeking a Local Study Associate Director (Clinical Operations Leader) to join us in the UK. You will be assigned to one of our key sponsors in the region.
Working as a Local Study Associate Director (LSAD) at Parexel FSP offers long-term job security and growth opportunities. We undertake vital clinical studies for sponsors including leading global biotechs and Pharma top 50, with an impressive pipeline of work.
Whether your future path is in clinical operations, project management, line management, or other roles, we offer a world of opportunities.
Our LSADs work remotely from their home office, supporting studies within their country or region. Our mantra is ‘Manageable sites, manageable protocols’. Expect professional challenges in inspiring studies, balanced with time for your personal life.
Role specifics:
* Dedicated to one client.
* Responsible at the country level for delivering clinical study components according to resources, budget, timelines, and compliance with Client Procedural Documents, ICH-GCP, and local regulations.
* Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budgets in the financial system.
* Leads and optimizes the performance of the Local Study Team(s), ensuring compliance with procedures and regulations.
* Prepares country-level Master Informed Consent Forms (MICF) and site-level ICFs, including translations, in line with SOPs and regulations.
* Ensures timely submission of applications/documents to EC/IRB at study start-up and throughout the study.
Requirements:
* Minimum of 3 years' experience managing local clinical trials.
* Proven leadership and motivation skills to deliver trials on time, within budget, and with quality.
* Willingness and ability to monitor oncology trials as needed.
* Experience with submissions to Regulatory Authorities and Ethics Committees.
* Ability to collaborate with study functions for smooth delivery.
* Strong organizational, interpersonal, and problem-solving skills; ability to multitask and prioritize.
* Good understanding of clinical research phases, GCP/ICH guidelines, and local laws.
We value our people and foster an open, friendly environment that empowers growth and development within Parexel.
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