Clinical Data and Documentation Coordinator

Highly Competitive Salary
  1. Contract
  2. Clinical Trial Assistant (CTA)
  3. United States
Cambridge, USA
Posting date: 19 Sep 2019
CR.NR.25458_1568928935

Proclinical is currently recruiting for a Clinical Data and Documentation Coordinator for a global pharmaceutical company located in Cambridge, MA. Successful candidate will work closely with Manager and Clinical Operations personnel to perform quality checks and file Clinical Trial Master File (TMF) to ensure high quality documentation in accordance with country-specific regulations, ICH Guidelines, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs) and Business Practices.

Job Responsibilities:

  • Conduct 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.
  • Scan, file and maintain study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system.
  • Provide 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 and contribute to processes and tools in support of maintaining operational and document management systems to ensure quality and completeness.
  • 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 with 2-5 years of industry or comparable experience
  • Candidates with some clinical research educational courses and knowledge of regulatory and Good Clinical Practice 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
  • Internal candidates must have demonstrated high performance in current position

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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#Clinical

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