Clinical Documents Management Specialist

2+ years

Not Disclosed

Remote, USA

10 Nov. 21, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Document Manager – eTMF
Company: Katalyst Healthcares & Life Sciences
Location: Remote
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in clinical research for drugs, biologics, and medical devices. We have immediate job opportunities available in Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with leading university hospitals, pharmaceutical companies, and recruiting partners to support clinical trials and product development.

Job Description:

We are seeking a Clinical Trial Document Manager to support the management and maintenance of trial-related documents. The ideal candidate will oversee the setup and upkeep of the Trial Master File (eTMF) and Investigator Site File (ISF), ensuring compliance with regulatory guidelines and operational standards.

Responsibilities:

Take operational responsibility for setting up the local Trial Master File (eTMF) and Investigator Site File (ISF), including tracking and maintaining documents.
Ensure the TMF is accurately maintained, compliant with International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and meets local requirements.
Support the Clinical Research Associate (CRA) in the maintenance and closure activities for the ISF.
Contribute to the creation and maintenance of clinical study documents, ensuring compliance with templates and version control.
Import clinical-regulatory documents into the Global Electronic Library (GEL) and manage according to the Global Document List (GDL), ensuring compliance with publishing guidelines.
Assist in electronic applications/submissions, ensuring documents meet Submission Ready Standards (SRS).
Manage tracking and communication tools such as IMPACT and SharePoint, providing support for their use.
Provide training and guidance on study administration procedures to team members.

Qualifications:

Bachelor’s degree preferred.
3-5 years of experience in clinical trial document management and regulatory documents.
Experience with electronic Trial Master File (eTMF) systems, including uploading, reviewing, QC, and approval of study documents.
Solid understanding of the clinical study process and knowledge of ICH/GCP guidelines.
Familiarity with clinical study documents and the regulatory requirements for them.
Advanced computer skills and proficiency with document management tools.
Strong verbal and written communication skills.
Excellent organizational, time management, and multitasking abilities in a high-volume, fast-paced environment.
Team-oriented with the ability to work effectively in an international team.

Additional Information:

All your information will be kept confidential according to EEO guidelines.

Apply Now: Katalyst Healthcares Careers

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Clinical Documents Management Specialist

Job Description

Company Overview:

Job Description:

Responsibilities:

Qualifications:

Additional Information:

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