The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.
We are currently looking for an enthusiastic and talented Document Specialist. This role can be home-based in Romania, the UK, Spain, and Portugal.
Core Accountabilities
TMF Operations responsibilities with regards to planning, processes, systems, and training to ensure corporate and compliance needs are met, as well as actively participating in or leading the resolution of any related matters.
Accountable for the management of assigned TMF Operations tasks, including Trial Master File documentation. Adhere to processes and procedures as documented in relevant Standard Operating Procedures (Aixial or Sponsor) and related documents.
Principal Responsibilities
eTMF/Electronic Document Ownership
* Deliver eTMF services to contractual and compliance expectations
* Deliver electronic documents to Sponsor where Aixial is not holding/accessing a TMF
* Follow Aixial/Sponsor SOPs
* Liaise directly with clients as required
eTMF / Electronic Document Management
* Maintain the assigned eTMFs in an audit-ready state
* Administers eTMF user training and access
* Perform accurate and timely filing and QC of clinical trial documentation; maintains TMF for conduct period of a project
* Conduct periodic quality reviews of TMFs, report findings and confirms closure
* Respond to requests regarding clinical trial documentation and TMF systems
* Prepare TMFs for archival to the Sponsor
Accountability for TMF activities
* Work independently on assigned projects, e.g. specific Trial Master Files or associated tasks.
* Knowledge of TMF Plans, applicable SOPs and systems
* Workload management and accountability to deliver all scheduled tasks within agreed timelines and budget
* Act as point of contact for wider departments, to provide status reporting and problem solving
* Assess accuracy and timeliness of associated work, and implement solutions
* Participate in system validation and management
* Provide training, mentoring, coaching for assigned TMFs
General
* Supports setup and user administration of other management systems, e.g. DocuSign, Clinical Database Platforms
* Provide training, mentoring, coaching and/or other support to colleagues, as required
* Follow ICH-GCP, CFR Part 11, appropriate regulations and company SOPs
* Timely and accurate entry of relevant study information in the time recording system
Essential Work Experience, Qualifications and Knowledge
* Proficient in MS Office (particularly MS Word and MS Excel)
* Technically-oriented with ability to learn various associated systems
* Experience working in the clinical trial industry
* Experience within TMF Operations in clinical trial industry
* Experience with Veeva Vault and eTMF
Desirable Work Experience, Qualifications and Knowledge
* A science or health related university degree would be highly advantageous
* Experience working in a document management environment (e.g. archive, library)
Additional
* The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
* The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Required skills and qualities
Planning and Organisational Skills
* Self-starter
* Very good attention to detail, and care and concentration in the accurate handling of important documentation
* Excellent organisational skills
* Ability to work calmly under pressure, respond positively to change, and prioritise workload
* An investigative and meticulous approach to all activities and tasks
Communication and Teamwork
* Professional, positive and enthusiastic attitude, with good interpersonal and communication skills
* The ability to work effectively and efficiently with internal partners within Aixial
* The ability to fulfil client expectations and satisfaction within compliance and contractual requirements
Technical skills
* Adaptable to work under different processes and systems, based on client needs
* Eagerness to learn and develop new skills
Languages
Fluent in spoken and written English
For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
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