Praca: TMF Manager
Ogłoszenie numer: 5645223, from 2021-10-12
Phlexglobal is the leading technology and services organisation 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 organisations to a new level of effectiveness.
Job can be done fully remotely (covering US EST Working Hours).
- Serve as the steward of the study eTMF to make sure the process to ensure completeness, quality and timeliness is followed by the study team.
- Support the study team by ensuring all members have access to the eTMF and have been appropriately trained to conduct their activities in the TMF.
- Present on TMF expectations at study Kick-off and TMF initiation meetings and others as necessary and attend regular study team meetings to report on the status and health of the TMF.
- Prepare the study TMF plan and corresponding study inventory list and insure they are current throughout the study and accurate at study completion.
- Train the study team and ensure quality / inspection readiness reviews are conducted as prescribed in the TMF plan and that issues identified are addressed.
- Manage document requests and quality issues related to the TMF throughout the duration of the study.
- Conduct general documentation reviews of the TMF looking for areas missing significant documentation, logical checks, gross errors in location, inconsistencies in naming conventions.
- Effectively communicate, support and drive document management compliance and quality issues to the clinical study teams and management.
- Support the clinical study teams to ensure study TMFs are submission and inspection ready at all times; as necessary raise challenges, work with stakeholders to develop effective action plans and resolve with appropriate documentation.
- Support the study team during inspections and audits as necessary.
- Participate with CRO and study team as the TMF expert and answer filing, process or general eTMF questions.
- Bachelor’s degree or equivalent and 3 years equivalent experience.
- A demonstrated, deep understanding of the TMF Reference model and passion for the TMF.
- Dedication to compliance and standards and ensuring process adherence.
- Demonstrated ability to prioritize and manage multiple projects simultaneously.
- Demonstrated ability to work effectively with many different types of personalities at all levels of the organization.
- Excellent interpersonal, collaboration and stakeholder management skills.
- Excellent customer service & English communication skills (written/verbal).
- Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure.
- Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking.
- Highly proactive, flexible, curious and resilient.
- Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint.
- Ability to travel (<10%).
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities. Our benefits include MyBenefit card, private healthcare, life assurance, English lesson and flexible working arrangements.
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.