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3 days old

Clinical Studies Specialist

Kelly Services
North Chicago, IL 60064
Kelly Services is currently seeking multiple **Clinical Studies Specialists** for a remote assignment working with a leading biopharmaceutical company.


Duration: 1 year


Pay rate: $27 per hour


Performs key operational activities across the Clinical Documentation Center for master files through life cycle. Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files; may be aligned by Therapeutic Area but expected to work across all areas of the organization.


Applies critical thinking to ensure real-time inspection readiness of clinical documentation by: investigates and proactively resolved issues runs and performs review of reports and dashboards within eTMF - produces eTMF metrics - communicates to Master File owner(s) "root cause" analysis and potential data integrity concerns


Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).


For CRO managed study TMFs: conduct QC of artifacts (may also include uploading and classifying); involvement with transfer of CRO TMFs into AbbVie eTMF system


Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files): - conduct data integrity checks - run & analyze reports for TMF completeness - work with the assigned CDA to follow-up on outstanding items with other functional areas - contribute to completion of pre-inspection requests


During an inspection: - function at the subject matter expert of the eTMF system navigation, including being present in the "front room" with the Auditors/Inspectors - participate in responding to auditor/inspector requests (may be required to put the response together)


Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-13 Expires: 2021-10-14

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Clinical Studies Specialist

Kelly Services
North Chicago, IL 60064

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