Distribution Study Set Up Approver

The Distribution Study Set Up Approver assists the Senior Distribution Study Set Up Approver with the daily approval of minor study amendments, new study set ups and major study updates as per standard operating procedures, internal distribution instructions and client requirements. Working in partnership with the amendments team, study set up team and Client Services project managers, this role requires close attention to detail and the ability to meet tight timelines while ensuring critical checks are completed and verified.,

• Review of study set up documentation against client requirements and standard operating procedures to ensure study set up is accurate. To provide feedback to study set up team on observations and errors encountered during review process. Approve GPM and associated documentation as per standard operating procedures!


• Review new and existing standard operating processes and associated documentation relating to study set up approval and related process.


• Maintain study set up approval SME status for the department, participate in process improvement and work to resolve any operational issues related to study set up.


• Provide support for investigations associated with distribution study set up using SME technical knowledge. Obtain a working knowledge of Trackwise to enable investigation reports to be completed where appropriate.


• Assist in internal and client audits as required.


• Participate in the training and onboarding of new team members.


• Perform other duties as requested by line management.
  
  Degree level or equivalent in relevant subjects desirable but not essential if relevant experience.


• Related experience in pharmaceutical GMP / Logistics or Supply Chain.


• Experience of working in clinical trials quality/distribution (IMPs, clinical trials) desirable.


• Ability to work with a team providing support to other members.


• Ability to work without direct supervision/on own initiative within the remit of the role.


• An understanding of GMP desirable.


• High degree of accuracy, concentration, accountability and verbal and written communication.
  
  When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world., At Thermo Fisher Scientific, each one of our 110,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.