Category

Description

• • Support the Head of RM to successfully lead the global RM function including storage location and conditions, access, back-up, naming conventions, transfer, handover, retention and archiving of both project specific and non-project specific documents and the records – management staff.
  • Work closely with the Head of RM to provide regular updates of the progress within RM, as a direct link from RM Associate staff.
  • Assist with the maintenance of efficient inventories and/or lists wherever necessary for the acknowledging the receipt of handed over or transferred documents, documents in temporary storage and those sent for archival.
  • Aid the management and storage of document transmittal forms and maintain a list of documents returned to the sponsor as per contractual obligations.
  • Be aware of both internal and external business regulations and environments and specifically, keep track of ongoing projects for accurate documentation purposes.
  • Take initiatives to prevent premature damage, destruction or tampering with documents.
  • Aid with the periodic assessment of electronic documents including essential documents and transferred documents for temporary storage and archival.
  • Effectively communicate with the Head of RM or Compliance manager regarding any issues related to Clintec Documentation.
  • Provide input and support in the development process and validation of electronic document management systems.
  • Quality check clinical trial documentation and monitor project mailboxes
  • Deputy Archivist – back up for Head of Records Management
  • Perform ad hoc tasks as required by the Head of RM.

• • Minimum of 3 years’ experience in a Pharma related / clinical research or administrative role
  • Non-essential but beneficial to have a Bachelor’s degree in a scientific field or nursing with relevant industry experience.

• • Attention to detail with a quality driven mindset
  • Ability and willingness to learn new technologies and processes
  • Personal integrity
  • Proficient in Microsoft Office suite and proven track record of technical competencies with respect to RM and archiving.
  • Possesses good communication skills, demonstrated leadership/ managerial abilities and problem-solving skills.
  • Competent in the documentation and management of documents within the framework of clinical trials as well as non-clinical records pertaining to business.

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