TMF Lead

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

JOB SUMMARY:

The TMF Lead (TMFL) coordinates 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. The TMFL is a member of the Centralized Clinical Trial Services staff.

Requirements

JOB RESPONSIBILTIES:

TMF Management:

• 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. 

Quality Management:

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

Account Management, Sales & Acquisition

• Assure good communication and relationships with (future) clients.
• Contribute and take part in client evaluations, visits and bid defenses.

Other:

• Contribute to other areas of business as required.

QUALIFICATION REQUIRED:

• Life science, healthcare and/or business degree
• Minimum 4 years of relevant experience filing documents in the TMF and managing the quality of the TMF.
• Minimum 4 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.

SKILLS:

•  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.
• Administrative excellence. 
• 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

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Leadership and ment