Senior TMF Specialist (232509)  Remote

Engineering Services | Healthcare IT | Life Sciences & Technology
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 Remote

Start Date: ASAP

Duration: 6-12 months

Hours: 40 hours a week

Description:

Our client is looking for a TMF SME to help conduct file reviews. These TMF’s are from their CRO’s and sponsor. This is not a TMF audit so auditing is not required, but would be a plus due to this being a part of their Inspection Readiness project. They need this person to be independent and someone who is nimble to technology. Their system is “clunky” (Veeva) and so that will slow someone down who is not technically savvy. This person will not be auditing the TMF’s, but if they have audited in the past that would be a plus. This is a due diligence process and they need someone doing cross reviews from one document to another so that the documents should be in there by cross reference. Anyone with health review language would be helpful. Oncology or Rare Disease is a must (Oncology preferred over Rare.)

Below are so more specific details for the responsibilities:

Perform a comprehensive and thorough review of the study/site trial master files (TMF) via quality content review, cross-referencing, and completeness review; including confirmation that the content collectively provides an accurate reconstruction of the trial.
Liaises with client’s functional groups to reconcile trial master file documents which have been received to ensure completeness and accuracy of file reviews.
Ensures documents are effectively remediated and indicated as resolved/closed in trackers, in accordance with metrics timelines; for external documents, confirm documents were appropriately filed by external vendors; for internal documents, confirm documents were appropriately filed in the Client TMF.
Adheres to SOP’s, work instructions, metrics timelines, and relevant process-supporting guidance
Provide support to TMF Operations during audits and/or regulatory inspections
Complete relevant study-specific training for assigned studies
Monitor and identify study/site TMF trends, communicate issues, and escalate concerns to Clinical Quality
Establish themselves as a reliable, trusted resource of accurate, up-to-date study TMF information as requested by key stakeholders

Education and Skills Requirements:

BA/BS required with 6 years of clinical research experience; or advanced degree in scientific discipline with 5 years clinical research experience
Good Clinical Practice (GCP) Auditing, or TMF inspection readiness, or Clinical Research Associate (CRA) or Clinical Trial Associate (CTA) experience required
Subject matter expert level knowledge of clinical study file documents, clinical trial activities, and terminology
Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization guidelines
Possess ability to effectively manage studies/sites residing with multiple CRO’s in various locations with differing filing structures
CRO/vendor management experience and DIA TMF Reference Model exposure preferred
Must have ability to navigate multiple electronic TMF system (Veeva) and advanced proficiency in Word, Excel, and PowerPoint

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Senior TMF Specialist (232509)  Remote

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote, United States

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