Senior Clinical Study Manager
4 days ago
Job Overview:
">Parexel is seeking a skilled Senior Clinical Study Manager to lead Local Study Teams in Canada. Experience with cell therapy is highly desirable.
">The Senior Clinical Study Manager will oversee the delivery of committed components of clinical studies according to agreed resources, budget, and timelines while adhering to Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.
">This role involves site monitoring as needed to support the flexible capacity model and ensuring sites are identified, qualified, set up, initiated, monitored, closed, and documentation archived.
">Trial and Site Administration:
">- Responsible for study commitments within the country and timely delivery of data to required quality.
- Leads Local Study Teams consisting of CRAs, CSAs, for assigned studies.
- Liaises with Line Managers at country level on study/ies and planned study milestones/key issues.
- Provides regular information to stakeholders on study progress/update.
Document Management:
">- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs.
- Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
- Ensures completeness of the eTMF and essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Ready”.
Regulatory and Site Start Up Responsibilities:
">- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
- Collaborates with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study.
Budgeting, Agreements, and Payments:
">- Prepares country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system.
- Ensures timely preparation of local Master Clinical Study Agreement (CSA) and amendments as needed.
Salary:
">$85,000 - $120,000 per year based on experience and qualifications.
">Requirements:
">- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields.
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
About Parexel:
">Parexel is a leading global biopharmaceutical services company that provides solutions to help clients accelerate and improve their development, manufacturing, and commercialization of innovative new treatments.
">Benefits:
">We offer a competitive salary and benefits package, including health insurance, retirement plan, paid time off, and opportunities for professional growth and development.
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