The Trial Master File (TMF) Specialist supports the clinical study team in all aspects of the maintenance of the study TMF by supporting the Study Delivery Lead (SDL) and document owners and addresses ad-hoc issues being the Trial Master File (TMF) study owner.
Ensure high quality and up-to-date TMF management being embedded in different clinical study teams Own and maintain the study TMF management plan and ensures adherence by the study team members Support the SDL in planning and executing TMF management-related activities of the clinical trial team in order to ensure that the TMF is in good shape and updated on a timely manner. Responsible to track eTMF-periodic reviews for studies and provide regular updates to the SDL/Head TMF Operations Primary point of contact for study team members for any TMF-related question In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system) In charge, during the maintenance of the TMF that the contributors are providing their documentation on an in-stream basis (by running KPI, by running reports, by running QC checks if needed). Take the appropriate relevant actions to address gaps, issues and risks Provide training to newcomers and refresher training to existing users Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archiving team for long term retention May lead inspection/audit preparation related activities with regards to study-related documentation
Academic & Professional Qualifications:
Degree in administration, office management or scientific degree Relevant working experience in a pharmaceutical / scientific environment is a must as well as knowledge of clinical trials (including ICH-GCP) and exposure to document management Skills & Experience
Expertise in project planning & project management is an asset Ability to set and manage priorities, performance targets, multiple tasks and project initiatives in a global environment Provide negotiation and presentation skills and be customer oriented Ability to work independently, within a team in a matrix organization connecting with a broad range of cultures Organized, methodical and attention to detail and conflict resolution
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
Who We Are
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our "Shared Work - Shared Vision" philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients' safety and comfort helps us to establish ethical standards for everything we do.
We are an Equal Opportunity Employer. No job applicant or employee shall receive less favorable treatment or be disadvantaged because of their gender, marital or family status, color, race, ethnic origin, religion, disability or age; nor be subject to less favorable treatment or be disadvantaged on any other basis prohibited by applicable law. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact