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This role maintains client's TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices.

Responsibilities

Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs).Performs set up activities, document filing and oversight of internal e/TMF applicationsSupports Clinical Operations Study Leaders in the QC and oversight of CROs' e/TMF applicationsFunctional lead for specified e/TMF platform with vendor(s)Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelinesProvide training to eTMF users and external parties (CROs)Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisionsSupports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriateCreates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document controlUpdates and maintains Naming and Filing Guide(s) for relevant e/TMF systemsWork in collaboration with all applicable functional areasWork in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate

Qualifications

Bachelor's degree or equivalent combination of education/experience in science or health- related fieldMinimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organizationThorough knowledge of all sections of the DIA Reference Model (current version)Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirementsThorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principlesExperience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals

Additional Experience

Motivated self-starter who is capable of flourishing in a fast-paced small company environment. Creative problem solver with excellent communication and public speaking skills. Proficiency in developing and delivering educational materials, both written and oralAbility to engage in cross-functional interactions with internal and external staffGlobal trial experienceStrong interpersonal and organizational skills are needed, with a high degree of attention to detail. P1399836BOSJB_1733241823 To Apply for this Job Click Here