Document Specialist - ROMANIA/UK/EU (CP08Ti620)

<p class="MsoNormal">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.</p><p class="MsoNormal">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 &amp; gene therapy, radiopharmaceuticals and rare diseases.</p><p class="MsoNormal"><span style="font-family: 'Arial',sans-serif;">We are currently looking for an enthusiastic and talented Document Specialist. This role can be&nbsp;<strong>home-based in Romania, the UK, Spain, and Portugal. </strong></span><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">Core Accountabilities:&nbsp;</span></strong></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">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.</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">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.&nbsp;</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">Principal Responsibilities:</span></strong></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">eTMF/Electronic Document Ownership</span></strong></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Deliver eTMF services to contractual and compliance expectations</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Deliver electronic documents to Sponsor where Aixial is not holding/accessing a TMF</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Follow Aixial/Sponsor SOPs</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Liaise directly with clients as required&nbsp;</span></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">eTMF / Electronic Document Management</span></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Maintain the assigned eTMFs in an audit-ready state</span></li><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Administers eTMF user training and access</span></li><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Perform accurate and timely filing and QC of clinical trial documentation; maintains TMF for conduct period of a project</span></li><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Conduct periodic quality reviews of TMFs, report findings and confirms closure</span></li><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Respond to requests regarding clinical trial documentation and TMF systems</span></li><li class="xmsonormal" style="mso-list: l7 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">&nbsp;Prepare TMFs for archival to the Sponsor</span></li></ul><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">Accountability for TMF activities</span></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Work independently on assigned projects, e.g. specific Trial Master Files or associated tasks.</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Knowledge of TMF Plans, applicable SOPs and systems</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Workload management and accountability to deliver all scheduled tasks within agreed timelines and budget</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Act as point of contact for wider departments, to provide status reporting and problem solving</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Assess accuracy and timeliness of associated work, and implement solutions</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Participate in system validation and management</span></li><li class="xmsonormal" style="mso-list: l4 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Provide training, mentoring, coaching for assigned TMFs</span></li></ul><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">General</span></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l2 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Supports setup and user administration of other management systems, e.g. DocuSign, Clinical Database Platforms</span></li><li class="xmsonormal" style="mso-list: l2 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Provide training, mentoring, coaching and/or other support to colleagues, as required</span></li><li class="xmsonormal" style="mso-list: l2 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Follow ICH-GCP, CFR Part 11, appropriate regulations and company SOPs</span></li><li class="xmsonormal" style="mso-list: l2 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Timely and accurate entry of relevant study information in the time recording system<strong>&nbsp;</strong></span></li></ul><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">Essential Work Experience, Qualifications and Knowledge:</span></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l0 level1 lfo4; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Proficient in MS Office (particularly MS Word and MS Excel)</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo4; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Technically-oriented with ability to learn various associated systems</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo4; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Experience working in the clinical trial industry</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo4; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Experience within TMF Operations in clinical trial industry</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo4; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Experience with Veeva Vault and eTMF</span></li></ul><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p><p style="margin-left: .5in;"><strong><span style="font-family: 'Arial',sans-serif;">Desirable Work Experience, Qualifications and Knowledge:</span></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l1 level1 lfo5; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">A science or health related university degree would be highly advantageous</span></li><li class="xmsonormal" style="mso-list: l1 level1 lfo5; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Experience working in a document management environment (e.g. archive, library)</span></li></ul><p class="xmsonormal"><strong><span style="font-family: 'Arial',sans-serif;">&ensp;&ensp;&ensp;&ensp;&ensp;&ensp;Additional</span></strong></p><p class="xmsonormal" style="margin-left: 1.0in; text-indent: -.25in;"><span style="font-size: 10.0pt; font-family: Symbol;">&middot;</span><span style="font-size: 7.0pt; font-family: 'Times New Roman',serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 'Arial',sans-serif;">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.</span></p><p class="xmsonormal" style="margin-left: 1.0in; text-indent: -.25in;"><span style="font-size: 10.0pt; font-family: Symbol;">&middot;</span><span style="font-size: 7.0pt; font-family: 'Times New Roman',serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 'Arial',sans-serif;">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.</span></p><p class="xmsonormal" style="text-align: justify;"><strong><u><span style="font-family: 'Arial',sans-serif;">Required skills and qualities</span></u></strong></p><p class="xmsonormal"><strong><span style="font-family: 'Arial',sans-serif;">Planning and Organisational Skills:</span></strong></p><ul style="margin-top: 0in; flex-direction: column; display: flex;" type="disc"><li class="xmsonormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Self-starter</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Very good attention to detail, and care and concentration in the accurate handling of important documentation</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Excellent organisational skills</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Ability to work calmly under pressure, respond positively to change, and prioritise workload</span></li><li class="xmsonormal" style="mso-list: l0 level1 lfo1; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">An investigative and meticulous approach to all activities and tasks</span></li></ul><p class="xmsonormal"><strong><span style="font-family: 'Arial',sans-serif;">Communication and Teamwork:</span></strong></p><ul style="margin-top: 0in; flex-direction: column; display: flex;" type="disc"><li class="xmsonormal" style="text-align: justify; mso-list: l2 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Professional, positive and enthusiastic attitude, with good interpersonal and communication skills</span></li><li class="xmsonormal" style="text-align: justify; mso-list: l2 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">The ability to work effectively and efficiently with internal partners within Aixial</span></li><li class="xmsonormal" style="text-align: justify; mso-list: l2 level1 lfo2; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">The ability to fulfil client expectations and satisfaction within compliance and contractual requirements</span></li></ul><p class="xmsonormal" style="text-align: justify;"><strong><u><span style="font-family: 'Arial',sans-serif;">Technical skills</span></u></strong></p><ul style="margin-top: 0in;" type="disc"><li class="xmsonormal" style="mso-list: l1 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Adaptable to work under different processes and systems, based on client needs</span></li><li class="xmsonormal" style="mso-list: l1 level1 lfo3; tab-stops: list .5in;"><span style="font-family: 'Arial',sans-serif; mso-fareast-font-family: 'Times New Roman';">Eagerness to learn and develop new skills</span></li></ul><p class="xmsonormal" style="text-align: justify;"><strong><u><span style="font-family: 'Arial',sans-serif;">Languages</span></u></strong></p><p class="xmsonormal"><span style="font-family: 'Arial',sans-serif;">Fluent in spoken and written English</span></p><p class="MsoNormal"><strong><span style="mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri; mso-bidi-font-family: Calibri; color: #656565; background: white;">For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - </span></strong><a href="https://www.aixialgroup.com/join-us/"><span style="mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri; mso-bidi-font-family: Calibri;">https://www.aixialgroup.com/join-us/</span></a></p><p style="margin: 0in 0in 12.0pt 0in;"><em><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif; color: #656565; background: white;">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.</span></em></p><p style="margin-left: .5in;"><span style="font-family: 'Arial',sans-serif;">&nbsp;</span></p>