Global Study Specialist (Canada)

Job Description Support clinical trial operations from study startup through closeout, ensuring timely and high-quality execution Manage regulatory and study documentation, including collecting, reviewing, tracking, and maintaining essential trial materials

•  Customize the study's Expected Document List (EDL) in collaboration with the CROs
•  Ensure handover documents are created, signed, and filed in TMF
•  Track document status, deadlines, and approvals; upload and organize files in accordance with study requirements Maintain and update clinical systems such as eTMF, CTMS, and SharePoint to ensure accurate and compliant record-keeping Coordinate with investigators, CRAs, and vendors to support study progress and document workflows
•  Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
•  Coordinate and oversee periodic study-level TMF/Master File (MF) QC
•  Provide continuous improvement by developing expertise in a specific area of study and/or EAP delivery, serving as a point of contact for best practice Ensure all documentation is inspection-ready and adheres to ICH-GCP and regulatory standards Support submissions to ethics committees and regulatory authorities, ensuring completeness and timeliness Assist with study closeout activities, including final document reconciliation and archiving Maintain Study Inspection Readiness Tool Support budget management activities• Raise POs & support invoice reconciliation •Candidates must reside in Canada within an Eastern Time Zone to qualify for this position We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements 1+ years of experience within clinical trials for a life sciences/pharmaceutical organization Oncology experience Strong documentation skills including maintenance of eTMF and CTMS systems Experience working with CROs GCP/ICH guideline adherence experience Real-world examples of meeting tight deadlines & working on multiple clinical trials at once, all at different phases Submissions experience Bachelors Degree in life sciences or related field