QC Specialist

TMF QUALITY SPECIALIST

DESCRIPTION

POSITION SUMMARY

The Trial Master File (TMF) quality specialist performs quality review of documents submitted for filing into TMF and collaborates with TMF importers/Managers to maintain the quality of the documents.

RESPONSIBILITIES

• Perform detailed quality checks of documents submitted for filing and uploaded into the TMFs
• Perform mandatory checks on all imported documents as per the defined QC checklist/criteria (eg scanning, legibility, completeness, duplicates etc)
• Communicate internal quality findings regarding the record to TMF importers for corrections
• Maintain a track of  QC check failed documents (rejected) and provide the same to the sponsor/TMF manager/TMF importer for resubmission.s
• Approve the documents for next stage of document life cycle
• Ensure that TMF filing is consistent with established processes and TMF specifications
• Provide support and feedback to study teams and TMF manager- IQVIA on resolution of Quality issues
• Monitor TMFs for trends, quality, and completeness
• Coordinate internal QC reviews of TMFs to ensure compliance and inspection readiness
• Verify essential documents are included in the TMF and are in the correct Official Repository at close-out verification
• Mentoring and training the new comers in the team

QUALIFICATION

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated proficiency with TMF Management. A minimum of 2 to 3 years of experience with eTMF is preferred
• Experience working with sponsor platform (CREDI/Subway) preferred
• Must have strong knowledge of DIA Reference Model for TMFs
• Experience in performing technical QC of the documents is preferred
• Working knowledge of clinical research documents
• Demonstrated current knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation
• Ability to work in an extremely fast-paced environment with changing priorities
• Ability to work collaboratively and cross-functionally
• Attention to detail and accuracy in work
• Skilled in verbal and written communication skills

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree, preferably in a scientific discipline, is required
• Computer literate with experience in Microsoft Office suite. Competency in Microsoft Excel is added advantage

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.
• Regular sitting for extended periods of time.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.