management, as Process Owner, with the aim of maintaining in good health the documentation
archived in the system. Acts as responsible for training both eTMF Assistant and eTMF Specialist on
documentation management and archiving procedures to ensure high documents quality standards. Contributes to the management and development of procedures relating to the activities in which is involved, ensuring that the activities of the whole Unit meet the quality standards required by the company.
This is a Remote (work from home) position.
Some of what you'll do:
- 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
- Identifies and analyzes 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 identifies study-specific eTMF trends and informs 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
What we're looking for:
- 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
What we offer:
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.
Please read the information notice on the processing of personal data in the candidates’ information section of our company website.
Who we are:
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.
Top Skills
What We Do
OPIS was founded in 1998 by medical doctors from the Pharma Industry and is a Global clinical CRO with 25 years of experience in a wide range of therapeutic areas. OPIS provides full-service, 360° clinical trial support from study concept creation and protocol development to full project execution, study data handling and up to study closure, analysis, and reporting. We manage Phase I-IV, interventional, non-interventional and medical devices studies on an international level. In addition, OPIS also manages pre- and post-marketing clinical investigations for medical and diagnostic devices, nutraceutical, and food supplement studies.
Our qualified, fully trained, and dedicated staff has managed 1470 studies to date.
OPIS’s strength lies in its people and its specialized teams who assist clients from A-Z with medical writing, scientific and statistical consultancy for trial design and skilled teams of operational staff that ensure high quality project execution, with global coverage.
Our mission is to increase the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system... etc.
OPIS is committed to continuous growth and expansion, while currently we have affiliates in 17 countries around the world.
For more information, visit www.opisresearch.com
