Clinical Trial Manager
Apex Systems, Waltham, MA, United States
Job #3031610
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.
Strong English communication skills.
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.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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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.
Strong English communication skills.
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.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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