Clinical Studies Specialist II
N Waukegan Rd North Chicago, IL 60048 US
Job Title: Clinical Studies Specialist II
Describe the primary goals, objectives or functions or outputs of this position.
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.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• 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 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 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).
• Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors. Provide approval for release of IP to investigator sites.
• Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.
• Complies with GCP, SOPs and functional area processes.
List required and preferred qualifications (up to 10). Include education, skills and experience.
• High school diploma or equivalent; Bachelor degree or international equivalent is preferred.
• With at least 4 years of professional work experience.
• Demonstrates analytical, critical thinking and organizational skills.
• Ability to independently perform multiple tasks at the same time.
• Good communication skills (oral and written)
• Proven effective, collaborative interactions with colleagues
• Experience working in electronic systems
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