Open to opportunities

Kena Cobb

@kenacobb

Message

Experienced clinical documentation specialist with 25+ years in pharmaceutical data and TMF management.

United States

Message

What I'm looking for

I seek roles ensuring TMF/eTMF inspection readiness, improving documentation workflows, and collaborating cross-functionally in regulated pharmaceutical environments.

I am a clinical documentation professional with over 25 years' experience in the pharmaceutical industry, specializing in Trial Master File (TMF)/eTMF management, clinical documentation quality control, label design, and customer-facing operations. I have a proven record of streamlining processes to reduce entry time for sensitive data, improving accuracy and efficiency, and maintaining inspection-ready documentation for audits and regulatory reviews.

I hold a Bachelor of Health Service Management and am pursuing a Master of Healthcare Administration. I have worked in both client and vendor roles supporting global studies, developed and maintained TMF structures, coordinated study shipments and materials, and partnered with cross-functional teams to ensure timely, compliant deliveries of clinical labels and documentation.

Experience

Work history, roles, and key accomplishments

Current

Clinical Documentation Associate

Current

Planet Pharma - Amgen

Oct 2021 - Present (4 years 8 months)

Manage and classify TMF/eTMF documents, perform first-pass quality reviews, and monitor TMF health metrics to maintain study inspection readiness and improve document accuracy and timeliness.

Clinical Documentation Regulatory Compliance

Clinical Studies Specialist II

USTechSolutions - AbbVie

Feb 2021 - Oct 2021 (8 months)

Owned Trial Master File for studies, performed QC to ensure real-time inspection readiness, developed TMF structure documentation, and supported audits/inspections.

TMF Quality Control Audit Support

Clinical Label Designer

Randstad - AbbVie

Jun 2018 - Feb 2021 (2 years 8 months)

Designed clinical labels per study protocols, maintained global phrase library and systems, coordinated approvals with Regulatory Affairs, and managed third-party label vendors to ensure compliant delivery.

Label Design Regulatory Compliance Global Phrase Library Vendor Management

Documentation Specialist Sr.

Collabera - AbbVie

Jan 2016 - Oct 2017 (1 year 9 months)

Scanned, indexed, and proofread patient and study documents, created electronic and physical document packages for investigators, and processed archival and submission requests to meet deadlines.

And Proofread Documents Document Management Systems Adobe

Customer Operations Specialist

PharMedium

Dec 2014 - Nov 2015 (11 months)

Managed order entry, invoicing, and dispute resolution; coordinated with compounding centers and internal teams; and supported hospital contract setups and pharmacy account creation for compounded drugs.

Order Entry Invoicing Customer Service Cross Functional Collaboration Credit Collections

Medical Research Information Specialist

Manpower - Abbott/AbbVie

Oct 2009 - Dec 2014 (5 years 2 months)

Entered medical information including CRFs and TMF materials, supported FDA/legal requests, created TMF medical packages, and contributed to process mapping and communications desk operations.

TMF FDA Requests Document Processing Process Mapping CTMS