Ogłoszenie numer: 4581053, from 2021-05-20
Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market.
As TMF Study Owner you will ensure that the clinical trial documentation is consistent with the Trial Master File (TMF) specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. The TMF Study Owner (SO) is the subject matter expert and single point of contact for the Project Manager (PM) or equivalent and Study Team.
TMF Study Owner
- Ensure consistent use of standardized processes and technologies across clinical trials and programs.
- Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
- Lead the set-up of the TMF Study Specific Document List (SSDL) and monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
- Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders (or completeness mechanism) are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
- Ensure complete TMF is in place at time of study close/submission.
- Support Study Team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics.
- Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.
- Serve as point of contact for internal and external audits of study TMF-related queries.
- Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes.
- Analyze error trends in documentation and provide feedback to their management and the TMF Director/Operations to enable continuous improvement.
- Provide education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
- Minimum 5 years of relevant experience in Clinical or TMF Operations oversight
- Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
- Experience/knowledge of ICH/GCP documentation requirements.
- Outstanding verbal and written communications skills combined with outstanding listening skills are required.
- History of achievement in building strong customer relationships. Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.
- Excellent English skill (both verbal & written)
- Experience with the following application types: Electronic documentation management systems, web-based data management systems, as required, and database utilization
Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities.
Your career and personal development are important to us. We provide you with all the training you need to develop the knowledge and skills to be successful at work. We also provide personalized learning and development plans, and regular performance reviews to enable you to achieve your career development goals.
Phlexglobal Poland Sp. z o.o.
Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness.
We have offices in the UK, US, India, Germany and Poland, to serve the needs of our global customers.