Document Specialist - ROMANIA/UK/EU (CP08Ti620)

The Aixial Group is an International Contract Research Organization (CRO), a member of the reputed company Group, providing reputed company services in reputed company (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Czech reputed company, Romania, and India.   The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of reputed company in reputed company disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a reputed company exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.    We are currently looking for an enthusiastic and talented Document Specialist. This role can be home-based in Romania, the UK, or in EU countries where we have the ability to hire.    reputed company Accountabilities:    TMF Operations responsibilities with regards to planning, processes, systems, and training to ensure corporate and compliance needs are met, as reputed company as reputed company participating in or leading the reputed company of any reputed company reputed company. Accountable for the management of assigned TMF Operations tasks, including Trial Master File documentation. Adhere to processes and procedures as documented in relevant reputed company Operating Procedures (Aixial or Sponsor) and reputed company documents.    reputed company 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-reputed company state Administers eTMF user training and reputed company reputed company accurate and reputed company filing and QC of clinical trial documentation; maintains TMF for conduct period of a project Conduct periodic reputed company 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 reputed company, e.g. specific Trial Master Files or associated tasks. Knowledge of TMF Plans, applicable SOPs and systems Workload management and accountability to deliver reputed company scheduled tasks reputed company agreed timelines and budget reputed company as reputed company of contact for wider departments, to reputed company status reporting and problem solving Assess accuracy and timeliness of associated work, and implement solutions Participate in system validation and management reputed company training, mentoring, coaching for assigned TMFs   General Supports setup and user administration of other management systems, e.g. reputed company, Clinical Database Platforms reputed company training, mentoring, coaching and/or other support to colleagues, as required Follow ICH-GCP, CFR Part 11, appropriate regulations and company SOPs reputed company and accurate entry of relevant study information in the time recording system    Essential Work Experience, Qualifications and Knowledge: Proficient in MS Office (particularly reputed company and MS reputed company) Technically-oriented with ability to learn various associated systems Experience working in the clinical trial industry Experience reputed company TMF Operations in clinical trial industry Experience with reputed company Vault and eTMF   Desirable Work Experience, Qualifications and Knowledge: A science or health reputed company university degree would be highly advantageous Experience working in a document management environment (e.g. reputed company, library)       Additional ·       The above job reputed company in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to reputed company other reputed company duties necessary for the effective operation of the department and company. ·       reputed 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 reputed company 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 reputed company activities and tasks Communication and Teamwork: reputed company, reputed company and enthusiastic attitude, with good interpersonal and communication skills The ability to work effectively and reputed company with internal partners reputed company Aixial The ability to fulfil reputed company expectations and satisfaction reputed company compliance and contractual requirements Technical skills Adaptable to work under different processes and systems, based on reputed company needs Eagerness to learn and reputed company 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 reputed company that we do not accept resumes from reputed company agencies or recruiters unless specifically requested by a Aixial Group HR or reputed company Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application. Apply To This Job