You are here
Clinical Research Specialist - Regional
- Regional scope of work
- Comprehensive salary and fringe benefits
About Our Client
My client is one of the market-leading global brands in medical device with a long history of product innovation and manufacturing excellence. They believe in empowering employees with opportunities to grow vertically or diagonally within the organization to fully develop their potential/interests.
- Function has project manager in leading and driving the planning, execution, and management of all aspects of clinical trials according to strategy, project plans, approved budgets.
- Ensure full compliance to applicable regulatory and standard operating procedures.
- Ensure that the rights and well being of subjects are protected, reported study data are accurate, and studies are performed in strict accordance with established protocols, SOPs, ISO/GCP standards, and other regulatory requirements.
- Produce clear written communication to all clinical sites and project team members in the form of monitoring reports, follow-up letters, study memos, and general correspondence.
- Ensure all site personnel are appropriately qualified/trained to conduct clinical studies in compliance with applicable regulations.
- Manage study contracts, request and collection of relevant (FDF, CV/ML) investigator/site documentation in database.
- Actively drive collaborative effort with cross functional team members and study sites throughout all study phases.
- Ensure adverse events are identified, clearly documented, and reported as per standard protocol.
The Successful Applicant
- A Bachelor's degree in the Health/Medical Sciences, ideally a Masters degree.
- At least 5 years of experience in clinical study planning, executing, and monitoring, with preferably a regional focus.
- First-class written and spoken communication skills.
- Manages work in a confidential manner, ensuring proprietary information is shared with internal and external stakeholders in an appropriate manner.
- The ability to function well in cross-functional projects and demonstrate leadership where necessary.
What's on Offer
Comprehensive salary package and fringe benefits, work life balance, regional exposure, a high-performing work environment, and career growth opportunities.