Document Specialist - ROMANIA/UK/EU (CP08Ti620)

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.

Responsibilities include:

• Maintaining TMF for the conduct period of a project.
• Conducting periodic quality reviews of TMFs, reporting findings and confirming closure.
• Responding to requests regarding clinical trial documentation and TMF systems.
• Preparing TMFs for archival to the Sponsor.
• Accountability for TMF activities.
• Working 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.
• Acting as point of contact for wider departments, to provide status reporting and problem solving.
• Assessing accuracy and timeliness of associated work, and implementing solutions.
• Participating in system validation and management.
• Providing training, mentoring, coaching for assigned TMFs.
• Supporting setup and user administration of other management systems, e.g. DocuSign, Clinical Database Platforms.
• Following 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).

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.
• 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.
• 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.