- Poste : Records Management Executive / Directeur/trice du Records Management.
- Employeur : Clintec, Glasgow (UK) / Société Clintec – Glasgow (Écosse, Royaume-Uni).
- Offre : recrutement contractuel : CDI.
[Annonce originelle rédigée en anglais]
EMPLOYEUR & CONTEXTE :
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec is actively recruiting for a Records Management Executive to join our expanding global company in our Glasgow Headquarters. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
POSTE & MISSIONS :
Job Code : 3376.
Role Purpose :
- Accountable for supporting the global management and archival procedure of Clintec’s documentation and records.
- Assisting the Head of RM with the safe storage, maintenance and retrieval of all records pertaining to the conduct of clinical research and Clintec’s business including assessment of compliance, or quality control, and/or standards defined for the management of documents for clinical trials in all countries.
- Ensuring and aiding proper documentation of transferred documents for maintenance and further archival and retrieval during the lifetime of clinical studies and retention at the end of study. Maintain complete, contemporaneous and quality records within an electronic trial master file system (eTMF) for global projects.
Responsibilities : Responsible for supporting the management of records and RM facilities while adhering to departmental policies and procedures :
- 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.
Conditions d’exercice :
- Job type : Permanent and Full Time Contract.
- Location : Clintec Headquarters, Glasgow UK.
- Recrutement : contrat à durée indéterminée à temps plein.
- Lieu de travail : poste basé au siège de Clintec à Glasgow (Écosse, Royaume-Uni).
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world’s leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.
Qualifications & Experience :
- 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.
Source : Clintec.