Sr. Manager/Manager, TMF Operations

Sr. Manager/Manager of TMF Operations
Cambridge, MA
Permanent Position

The Company:
This company is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates.?
The Position:
The Manager of TMF Operations will support the company's Trial Master File (TMF) Operations day-to-day management of TMF projects, TMF key performance indicator's (KPI's), electronic trial master file system (eTMF), and vendors TMF activities with a strong adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standards.
This position is highly visible and interactive with external vendors and cross-functional teams and plays a critical role in TMF management activities to ensure adherence to TMF Operations processes and compliance with applicable global regulations.
Primary Responsibilities Include:

  • Support eTMF systems, TMF Inspection Readiness Specialists, TMF Specialists, and Head of TMF Operations in day-to-day activities

  • Responsible for ensuring the trial master file is complete, contemporaneous, and quality.

  • Manages TMF projects and performs a risk-based review of TMF activities being performed by TMF Operations and external vendors.

  • Ensures key performance indicators are met and identifies any rate-limiting factors.

  • Manage TMF projects, assist with overall change management, and build collaborative relationships with cross-functional teams and external vendors

  • Provide support to TMF Operations during eTMF implementation, audits, and/or regulatory inspections

  • Ensure functional compliance with TMF SOP's, KPI's, relevant TMF process-supporting guidance's and applicable global regulations

  • Perform risk-based quality content reviews and monitor internal/external KPI's

  • Ensure the TMF is 'inspection ready' at all times

  • Manage TMF Room entry logs, document check in/check out logs, access, and temperature logs

  • Represent TMF Operations at study team meetings, participate in collaborative efforts and plays an important cross-functional role in TMF document retrieval and management?

  • Ensure documents which fail TMF quality content and/or TMF inspection readiness review are effectively remediated by internal/external representatives

  • Monitor and identify study-specific TMF trends and escalate concerns to Head of TMF Operations

  • Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies

  • Participate in TMF educational workshops and trainings?

Education and Skills Requirements:?

  • BS/BA degree required

  • Minimum 6 years clinical research experience with 4 years relevant document management, vendor oversight, quality content review, and comprehensive completeness review experience

  • Must be knowledgeable in domestic and global regulatory requirements and guidance's

  • Extensive TMF experience required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews

  • Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines

  • Subject matter expert level knowledge of clinical study file documents, TMF Reference Model, clinical trial activities, and terminology

  • Must have knowledge of Core, Country, and Site files and level-specific expected documents

  • Must have ability to manage and navigate multiple electronic TMF systems and advanced proficiency in Word, Excel, and PowerPoint

  • Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities?

  • Approachable and builds constructive, positive, collaborative relationships with key internal stakeholders and external vendors

  • Must be proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision

  • Must have excellent organizational skills, exhibit professionalism, communicate effectively, have a 'can do' approach, advanced problem-solving skills, and be a team player

Company Description:

About Ascent:

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.

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