ETMF Lead

Overview

The eTMF Lead, in compliance with the applicable procedures, is mainly responsible for the eTMF management, as Process Owner, with the aim of maintaining in good health the documentation archived in the system.

• Assist the project team members in the creation of a new study in the eTMF, completing the setup, in good coordination with the study team
• Deliver training to new eTMF users, providing a comprehensive overview of system functionality and operational workflows
• Follow up with the users to ensure that the training process has been completed before requesting the eTMF provider to grant access to the system, according to the related SOPs
• Manage user access rights, including assigning roles, study/group allocations, and deactivating accounts as required
• Provide support in case of issues experienced by the study team during eTMF utilization
• Act as back-up of the “Importer” or “QC Owner/Contributor” in the eTMF, with the aim of indexing/finalizing files in the system
• Ensure standardization, quality, and timely completion of clinical trial documentation across assigned studies, in line with eTMF specifications, ICH‑GCP guidelines, regulatory requirements, and internal SOPs
• Assist in the development and preparation of quality metrics and reports, based on Sponsor or project‑specific needs, including data extrapolation related to eTMF completeness, accuracy, and quality
• Provide assistance in preparing quality metrics, based on specific Sponsor/Project needs, supporting extrapolation of data about eTMF completeness, accuracy and quality
• In charge of the overall eTMF quality and completion, including appropriate document filing and maintenance, cross‑functional documents coordination, in cooperation of the study teams
• Identify and analyze issues affecting eTMF management, suggesting alternatives to improve processes
• Ensure that documents failing quality control or eTMF review are addressed promptly, and provide best practice guidance when necessary
• Monitor and identify study‑specific eTMF trends and inform the study team accordingly, if needed
• Serve as the main point of contact for Sponsor and Project team members as expert of eTMF functionalities, document content, applicable technologies and processes
• Develop eTMF specifications/guidelines and contribute to the preparation of study specific TMF Plans together with the clinical study representative
• Attend and lead dedicated alignment meetings with Sponsor and study teams
• Attend Bid defense meetings or pre‑awards call with Clients to present the activities under his/her responsibility
• Participate in inspections/audits conducted by Sponsor staff or internal OPIS staff, in compliance with OPIS SOPs

• Life science Degree
• Previous experience in similar role (at least 3 years) in the pharmaceutical, biotechnology, CRO industry
• Familiarity with document management systems and electronic databases
• Fluent English (written and speaking)
• Proficiency in MS Office Suite and other relevant software
• Excellent interpersonal, leadership and communication skills
• Exceptional attention to detail, accuracy and organizational skills
• Ability to multitask, prioritize work and meet deadlines
• Result/Team‑working oriented
• Strong problem‑solving and decision‑making abilities

We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth, innovation, and customer success.

OPIS is an International CRO with over 25 years of experience in conducting Phase I‑IV, non‑interventional and medical devices studies on an international level. We always offer state‑of‑the‑art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS extensive expertise covers all phases of drug‑related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices.

With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start‑up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.