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Regulatory and Clinical Operations Lead
2 weeks ago
About the Role
The Regulatory and Clinical Operations Lead will be responsible for managing the delivery of site activation, maintenance, and regulatory activities for assigned projects. This includes pre-award activities, oversight of the scope of work, budget, and resources.
Responsibilities:
- Oversight of the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Skills and Qualifications:
- Bachelor's Degree in Life sciences or related field.
- 7 years' relevant experience in a scientific or clinical environment, including demonstrable experience in an international role.
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
