Global Clinical Operations Specialist
5 dni temu
At TN Poland, we are seeking a highly skilled Global Clinical Operations Specialist to join our team. In this role, you will play a key part in the successful delivery of clinical trials by activating sites and ensuring compliance with applicable regulations.
About the Role:
We are looking for an experienced professional who can review project planning and timelines, negotiate clinical trial agreements (CTAs), and manage cross-functional teams to support timely site start-up. The ideal candidate will have a strong understanding of life sciences and be able to communicate complex legal and budgetary issues to internal and external stakeholders.
Responsibilities:
- Review and agree on project planning and timelines to ensure monitoring measures are in place and contingency plans are implemented as needed.
- Negotiate and manage CTAs with investigative sites and investigators to ensure successful outcomes.
- Collaborate with clinical and RSU teams to support timely site start-up and accurate forecasting of contract execution timelines.
- Review and negotiate budgets for CTAs based on calculations provided by sponsors.
- Communicate and explain legal and budgetary issues to internal and external stakeholders per project guidelines.
- Prepare and conclude amendments to CTAs based on client requested changes and study CTA guidelines.
- Appraise contracts for completeness and accuracy, and ensure adherence to department guidelines; correct documents and files changes to contracts (QC process).
Requirements:
- Bachelor's Degree in Life Science or related field.
- Minimum 3 years' prior experience in life sciences or similar.
- Strong analytical and problem-solving skills, with ability to handle change and ambiguity.
- Ability to work on multiple projects simultaneously and prioritize tasks effectively.
- Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs, and GCP/ICH.
About Us:
TN Poland is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to pushing the boundaries of human science and data science to create a healthier world.
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