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

Qualifications

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

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