Clinical Trial Documentation Specialist job in Boston, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Clinical Trial Documentation Specialist with a biotechnology company located in Boston, MA.

Job Responsibilities:

Conducts quality checks of the Clinical TMF documents.
Work with internal functional area document owners and CRO to remediate any issues identified with Clinical TMF documents during quality check.
Scans, files and maintains study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system.
Provides central support for uploading clinical TMF documents to EDMS to support key trial activities (e.g., regulatory submissions, clinical study reports etc.).
Work with GDO stakeholders to review and manage operational clinical trial data to ensure quality and completeness per data quality standards and specified system guidelines.
Provide centralized data entry support for operational systems ensuring alignment with data quality standards.
Review operational data to inform and document trends and risk areas to key stakeholders
Support other trial related operational activities as needed and assigned.

Skills and Requirements:

BA/BS
1-3 years of industry or comparable experience; candidates with some clinical research educational courses
Knowledge of regulatory and Good Clinical Practice (GCP) requirements preferred
Understanding of the Trial Master File including understanding of the DIA TMF Reference Model preferred;
Experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred
Proficiency with MS Office Applications, SharePoint, Visio, etc

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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