Collects trial specific requirements to ensure the correct set up of the TMF and creation of the study specific TMF plan.
Works with TMF Specialists to ensure document metadata entry accurately reflects trial specific requirements and is entered in a consistent manner.
Ensures that Essential Document Lists are regularly updated by the study team allowing the completeness of the TMF to be accurately assessed.
Oversees TMF document flow in ensure that documents are uploaded within required timelines.
Responsible for developing cross-functional relationships with internal and external stakeholders to ensure the successful management of the TMF.
Provides regular status reports to project manager and sponsor regarding the status of the TMF.
Conducts periodic quality reviews of study documents to identify missing documents or poor-quality documents. Where necessary liaises with the document owner to ensure that all findings are addressed in a timely manner.
Supports audits and inspections to ensure that auditors have access to the TMF, and queries are answered in a timely manner.
Manages TMF to agreed budget and if necessary, discusses out of scope work with the project manager.
Supports all Allucent staff, by giving feedback and training to effectively assess document quality and manage the TMF.
Drive completeness, quality and timeliness of TMF content for all assigned studies until close out.
Draft and contribute as Subject Matter Expert (SME) in the field of TMF lead activities to the evaluation/improvement of processes and procedures within the Quality Management System
Assure good communication and relationships with (future) clients.
Contribute and take part in client evaluations, visits and bid defenses.
Contribute to other areas of business as required.
Requirements
Life science, healthcare and/or business degree
Minimum 5 years of relevant experience filing documents in the TMF and managing the quality of the TMF.
Minimum 5 years of experience in drug development and/or clinical research
Good knowledge of GxP, GDPR/HIPAA and applicable (local) regulatory requirements
Excellent working knowledge of clinical trial documentation and TMF procedures including the DIA Reference Model
Good understanding of study documentation and accurate filing acquired from working within TMF groups or other functional areas within CROs or sponsor companies.
Thorough understanding of good document practice and ALCOA+ standards.
Good analytical skills to understand metrics and identify trends in system reports.
Strong written and verbal communication skills including good command of English language.
Representative, outgoing and client focused.
Ability to work in a fast-paced challenging environment of a growing company.
Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
Effective at problem solving, strategic thinking and conflict resolution.
Strong presentation and networking capabilities
Allucent Clinical Research Organization is dedicated to addressing the unique needs of small and mid-sized biotech companies in order to facilitate the development of novel medicines. We offer complete drug development solutions worldwide, encompassing clinical operations, biometrics, clinical pharmacology, consultancy, and a range of therapeutic areas. With over 30 years of experience across more than 60 countries, our customized partnership approach offers customers experience-driven insights and knowledge to help them successfully navigate the challenges of delivering cutting-edge patient therapies.
Allucent fosters a high-performance culture where we offer ongoing training, prioritize chances for organizational and personal growth, and remain steadfast in our dedication to providing exceptional, individualized customer care. We view regular, efficient, and transparent communication as essential to creating plans that will fulfill your objectives. To achieve operational excellence in terms of deadlines, quality, and costs, we offer lean project management.