Available Positions

eTMF Manager at Pharmaceutical Company in Cambridge, Massachusetts, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Cambridge, Massachusetts, United States
  • 10/17/20

Job ID: 70630

Job Description

We are seeking a Trial Master File (TMF) Manager to drive our TMF Health and Inspection Readiness initiatives. This role will require the successful candidate to be savvy collaborating with cross-functional teams that include our client, CRO, and eTMF vendor teams.


Roles and Responsibilities

·      Defines and executes processes and activities that ensure TMF Health and Inspection Readiness

·      Actively participates in study-specific meetings to promote standardization, identify common trends/issues across studies, and performs escalation when applicable

·      Liaises with study teams, CRO staff, and eTMF vendor personnel to ensure optimal relationships

·      Defines Key Performance Indicator (KPI) metrics which will provide insight to TMF Health and vendor oversight

·      Monitors the Quality Issues (QI) log and drive issues to resolution

·      Schedules and critiques periodic Quality Reviews performed by our eTMF vendor

·      Contributes to TMF standardization and Risk-based QC efforts


Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop trusting relationships, good conflict management, and negotiation skills. Demonstrated ability managing an inspection-ready eTMF, managing sponsor and vendor relationships, and creating innovative processes that promote TMF Health and vendor oversight.


Basic Qualifications

·      8+ years’ experience in Clinical Operations

·      5+ years of direct “Hands-on” TMF experience

·      Bachelor’s degree required; advance degree preferred


Preferred Qualifications

·      Experience in the Veeva clinical suite a plus

·      Solid understanding of clinical trials and drug development, Phase I through Phase IV

·      Ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe

·      History of authoring SOPs, WIs, Trainings, Job-aids, etc.

·      Experience with the DIA TMF Reference Model

·      Strong communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution,                  negotiation, and team-building skills

·      Flexibility to adapt to the dynamic needs of a fast-paced and innovative biotech company

·      Knowledge of Expected Document Lists and Milestone tracking

·      Track record of defining KPIs to measure TMF Health and vendor oversight

·      Familiarity with regulatory landscape such as FDA, ICH E6, MHRA, and EMA

·      Experience performing risk-based analysis


Explore your Recruiting Career

Discover the wide range of opportunities Green Key has to offer.

Learn More

Join Our Network

You’ve worked hard for your industry experience. Now put that experience to work.

Send us your resume

Green Key Blog

News for the way you work.

More from the blog