Allucent
Pharmaceuticals
TMFLead
Neural analysis suggests this role is
optimal for Mid candidates.
“TMF Lead at Allucent. Skills: TMF management, clinical trial documentation, document quality, stakeholder management. Coordinate management of trial master files (TMF).. Control and monitor trial team activities.”
What You'll Achieve.
inspection ready TMF for all assigned studies; completeness of the TMF to be accurately assessed; documents are uploaded within required timelines; findings are addressed in a timely manner; auditors have access to the TMF; queries are answered in a timely manner; Drive completeness, quality and timeliness of TMF content for all assigned studies until close out.
Industry & Context.
Effective at problem solving; strategic thinking; conflict resolution; analytical skills to understand metrics and identify trends
What They're Looking For.
Must Have
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., 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., Effective at problem solving, strategic thinking and conflict resolution.
What You'll Do.
Coordinate management of trial master files (TMF).
Control and monitor trial team activities.
and return inspection ready TMF.
Collect trial specific requirements for TMF setup.
Ensure accurate document metadata entry.
Update Essential Document Lists for TMF completeness.
Oversee TMF document flow and timelines.
Conduct periodic quality reviews of study documents.
Support audits and inspections.
Manage TMF to agreed budget.
Provide feedback and training on document quality.
and timeliness of TMF content.
Draft and improve processes within Quality Management System.
Assure good communication with clients.
Take part in client evaluations and bid defenses.
How You'll Work.
Team & Collaboration
Develop cross-functional relationships with internal and external stakeholders.; Liaise with document owners to address findings.; Support Allucent staff with feedback and training.; Assure good communication and relationships with clients.
Communication Scope
written and verbal communication skills; good command of English language
Process & Methodology
Manage TMF to agreed budget., Discuss out of scope work with project manager.
Full Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for TMF Lead to join our A-team (remote/hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial master files (TMF) for trials at Allucent. This position controls and monitors the activities of the trial team to create, maintain and return to the Sponsor an inspection ready TMF for all assigned studies. **In this role your key tasks will include:** * 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 T
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