Contract Clinical Trial Manager
Stratacuity: Proven Scientific Placement, Waltham, MA, United States
Our Waltham based client is seeking a Clinical Trial Manager to support clinical operations activities across oncology studies. This role focuses on TMF maintenance, study documentation, site support, and ensuring inspection‑ready quality throughout the trial lifecycle.
Responsibilities
Maintain the Trial Master File and ensure audit/inspection readiness.
Follow all SOPs, policies, and regulatory requirements; complete required training.
Track and collect essential regulatory documents from sites during start‑up and study conduct.
Support TMF QC, reconciliation, and document archiving.
Prepare study start‑up submissions and site files; ensure accuracy and completeness.
Maintain protocol and site information in trial management systems.
Assist with study data, budgets, payments, investigational product tracking, and correspondence.
Coordinate investigational product shipments and accountability.
Support CRF/CCG development, eTMF/database UAT, and process improvements.
Assist with SIV training, meeting logistics, agendas, and minutes.
Review site visit reports and support vendor management as needed.
Qualifications
BA/BS in Life Sciences, Nursing, or related field.
2+ years of clinical trial management experience, preferably in oncology.
Biotech/pharma experience is a plus.
Proficiency in MS Office and Adobe Acrobat.
Excellent organization, attention to detail, and ability to manage multiple priorities.
Comfortable working in a fast‑paced environment and across global time zones.
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Responsibilities
Maintain the Trial Master File and ensure audit/inspection readiness.
Follow all SOPs, policies, and regulatory requirements; complete required training.
Track and collect essential regulatory documents from sites during start‑up and study conduct.
Support TMF QC, reconciliation, and document archiving.
Prepare study start‑up submissions and site files; ensure accuracy and completeness.
Maintain protocol and site information in trial management systems.
Assist with study data, budgets, payments, investigational product tracking, and correspondence.
Coordinate investigational product shipments and accountability.
Support CRF/CCG development, eTMF/database UAT, and process improvements.
Assist with SIV training, meeting logistics, agendas, and minutes.
Review site visit reports and support vendor management as needed.
Qualifications
BA/BS in Life Sciences, Nursing, or related field.
2+ years of clinical trial management experience, preferably in oncology.
Biotech/pharma experience is a plus.
Proficiency in MS Office and Adobe Acrobat.
Excellent organization, attention to detail, and ability to manage multiple priorities.
Comfortable working in a fast‑paced environment and across global time zones.
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