Trial Master File (TMF) Lead (CP11Ti610)

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 TMF Lead to join our team. This is a remote full time contract for 1 year with possibility to extend or/and convert to permanent role. Accepting candidates from Romania, Spain, Portugal, and/or UK.  

Core Accountabilities:

Leadership of assigned TMF Operations areas of 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 content. Adhere to processes and procedures as documented in relevant Standard Operating Procedures (Aixial or Sponsor) and related documents.  

Principal Responsibilities:

·         Attends the project kick-off meeting with the appropriate project team members as TMF specific point of contact (SPOC).

·         Responsible for creation of the TMF Plan & project specific index, providing training on the eTMF platform and following company TMF SOP/processes.

·         Evaluates and provides recommendations to ensure TMF inspection readiness, identifies any project risks and issues and develops a plan to resolve these.

·         Monitors TMF completeness and performs completeness reviews, driving completeness and quality through milestone completion and closure of quality issues.

·         Generates and provides TMF Inspection Readiness reports to the Project Team.

·         Provides input to project specific queries in relation to the quality check.

·         Participates in any internal & external audits/Inspections

·         Attends project team or sponsor meetings where appliable in relation to the TMF.

·         Facilitates the export and shipment of the TMF per contracted scope and ensures delivery by agreed transfer date.

·         Has a thorough understanding of contracted scope, timelines, and budget for the TMF.  Documents any out-of-scope work and communicates this to the Project Manager to add to a Change Notification Form/Change Order, as required.

General: 

1. Supports setup and user administration of other management systems,
2. Provide training, mentoring, coaching and/or other support to colleagues, as required
3. Follow ICH-GCP, CFR Part 11, appropriate regulations and company SOPs
4. Timely and accurate entry of relevant study information in the time recording system

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.

Essential Work Experience, Qualifications and Knowledge: 

• Thorough knowledge of clinical Trial Master File process/activities, regulatory requirements and Good Clinical Practice
• Advanced knowledge of clinical documentation and reporting
• Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization • Ability to handle multiple tasks and projects within defined timelines and balance competing priorities • Excellent communication, organization and tracking skills
• Technically-oriented with ability to learn various associated systems

Desirable Work Experience, Qualifications and Knowledge:

·         Minimum 6 years’ experience in clinical development/clinical operations and minimum 3 years’ experience with document management systems and excellent understanding of system structures and generic document management functionality 

·         Fluent written and oral English

·         Veeva experience  

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.