The TMF manager is responsible for overseeing daily global management activities relating to clinical study Trial Master Files (TMF), including ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. The eTMF system has over 12,000 global users, including contract research organizations (CROs) vendors.Functions include:
- Managing Quality Control reviews of study TMFs to ensure they are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines;
- Managing the activities associated with the TMF business process, including continuous improvement activities and metrics, and archiving;
- Assisting with the oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;
- Liaising with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF
- The TMF manager will serve as Lead for one or more of the main processes within the department. This will include oversight and management of the end to end activities involved in the process.
- The TMF manager will supervise at least one two subordinates at same location, but will also provide guidance to other department staff globally.
- Additionally, the TMF manager will support the Head of TMF Process Management and QC Compliance in other areas within the department?s remit.
The TMF Manager will be required to work collaboratively with group members, business leaders, and contribute to positive team relationships, both locally and globally. This role will lead initiatives and serve as a subject matter expert in TMF Operations.I ncluding assisting in oversight of the eTMF vendor, ensuring service meets expectations; coordinating TMF set-up, training, resolution of queries, and the activities associated with Quality Control Reviews of study TMFs to ensure TMF inspection readiness.
Provide feedback to project teams and /or management on proposed solutions for the correction and resolution of TMF quality issues, TMF completeness and timely submission of documents to the TMF. Meet with Functional Area leaders to prioritize studies and liaise with CRO stakeholders to ensure consistent processes and procedures for the management of the TMF. Facilitate the development and revisions of departmental SOPs and work guidelines as needed. Prioritize workload and Manage the day to day activities of direct report(s)Job Qualifications
- Bachelor?s degree is required. in a scientific discipline (preferred.)
- Min of 5 years of experience in pharmaceutical environment; min of 2-3 years experience in clinical quality control, TMF/eTMF, clinical operations and/ or clinical document management preferred
- Some supervisory/line managing experience required.
- Must have good understanding of clinical development, including US and international regulatory requirements (including ICH and GCP guidelines) for the conduct of clinical trials and related regulatory documentation and be able to interpret and make decisions based on the interpretation of such guidelines.
- Must have strong knowledge of and be able to differentiate all key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents)
- Must have strong document management skills, including experience with review of Regulatory Documents, be quality driven and able to work in a team environment under tight deadlines
- Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred
- Must have critical reasoning skills, including the identification and resolution of complex problems
- Must be proficient in MS Office
- Shows high level of initiative and has ability to work independently
- Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team
- Ability to drive cross-functional projects with conflicting priorities
- Must be very detail oriented and possess excellent organizational and time management skills
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.