We are looking for: TMF Study Owner
Love TMFs but tired of Filing? Do you have what it takes to be a TMF Subject Matter expert? We have this exciting role for you if you do!
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.
PhlexTMF is the company’s Trial Master File software. Regulatory solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for out-of-the-box best practices capabilities, automation technology, and user-focused design. PhlexNeuron, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end-to-end solutions offering from Phlexglobal.
This is a home-based role that can be filled either in: United States, United Kingdom, India or Poland; remote working hours match the business day of the customer’s required working hours` time zone.
Communication, Collaboration and Customer Service
- Outstanding verbal and written communications skills combined with exceptional listening skills.
- Committed team player, able to build effective working relationships with individuals at all levels of the organization(s).
- Ability to remain calm and focused in high-stress situations with strong skills in negotiation and conflict resolution.
- History of achievement in building strong customer relationships with demonstrated evidence of meeting customer needs and concerns through positive feedback.
Clinical and TMF Expertise
- Minimum of 5 years relevant experience in Clinical or TMF Operations oversight.
- Thorough understanding of the processes associated with the conduct of clinical trials and document management operations, through industry experience.
- Experience in management of medical/clinical study records and documentation.
- Experience/knowledge of Regulatory Agency inspection expectations.
- Sound knowledge of ICH-GCP documentation requirements.
- Experience with the following application types:
- Electronic Trial Master Files (eTMF)
- Clinical trial management systems (CTMS)
- Electronic document management systems (EDMS)
- Other clinical trial data management systems, as required
- Adept at learning and become proficient in new applications.
Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits, and a comprehensive and competitive rewards package, including tailored training and personalized career development opportunities. Please find benefits for each individual country we are recruiting in:
United States – Our benefits typically include a competitive base salary and generous annual leave. We also provide 401k, medical, dental and vision insurance, short and long-term disability and life insurance.
United Kingdom – Our benefits typically include a competitive base salary and generous annual leave. We also provide a pension scheme, optional health insurance and an employee assistance programme.
Poland – Our benefits typically include a competitive base salary, 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.
Candidates who meet the above requirements and who are interested in a career with our company are asked to send their applications
in English (CV) at: firstname.lastname@example.org. We reserve the right to contact only selected candidates.