Clinical Document Specialist

Clinical Document Specialist

The Clinical Document Specialist is responsible for supporting key R D objectives with emphasis on Trial Master File TMF quality in accordance with Industry standards and GCP/ICH guidelines.

The Specialist will conduct routine TMF quality reviews and collaborate with Global Clinical Operations GCO and other functional areas to ensure TMF completeness and ongoing Inspection Readiness.

Responsibilities also include QC Review of Trial Documents e.g. Protocol, Investigator Brochure, Consent Forms, and eCRFs and posting clinical studies information including study results to applicable Clinical Registry e.g. ClinicalTrials.gov .

Works closely with the TMF Owner to assist in set-up, review, maintenance and archival of study-specific TMFs in accordance with industry standards and regulatory guidelines.

Perform TMF oversight through periodic risk-based quality reviews on trial records.

Provides reports of key performance indicators KPIs related to TMF accuracy, timeliness and completeness against milestone-based projections.

Proactively informs CO Study Team Leaders and Upper Managers of deficiencies from informal reviews. Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required.

Participates in quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary. posting clinical studies information including study results to applicable Clinical Registry e.g. ClinicalTrials.gov .

Performs the QC Review of Trial Documents Protocol, Investigator Brochure, Consent Forms, CSRs, and eCRFs and other documents as requested.

Performs Operation Checks of Trial Documents. Supports TMF Specialist in Change Incident Management, Risk Assessment and collaborates with the TMF Specialist as requested.

Provides Computer System Validation support during system configuration upgrades.

Participates in GCO Study Team meetings and eTMF QC meetings, as requested.

Assists in review and annotation of TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival.

Demonstrates technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements.

Maintains knowledge of current industry best practices.

Develops and maintains close working relationships with other functional areas outside of Global Clinical Operations e.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, CROs, Vendors etc. to facilitate TMF development.

Creates QC plan as needed. Ensures clinical documents are available for review and audit by QA department personnel and/or Regulatory agencies.

Performs document control specialist audits of Trial Master File as needed.

Performs other duties as necessary as assigned by management.

KNOWLEDGE AND SKILL REQUIREMENTS:

Minimum of one 1 year of experience in a biotechnology/pharmaceutical industry or other related relevant experience; BA/BS or equivalent experience preferred.

Experience with electronic trial master file system s including uploading, reviewing, QC, approval of study required documents.

Significant experience with Clinical Trial document management.

Demonstrated knowledge of regulatory requirements related to clinical trial document start up, retention and archival.

Proven ability to build and maintain effective internal and external relationships and successfully interact with various functional areas and levels.

 Excellent written and oral communication skills.

Experience using computer applications and eTMF system (preferably Veeva eTMF)

Demonstrated experience and ability to manage multiple projects/prioritize.

Working knowledge of GCP and ICH guidelines and other industry regulations.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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