Clinical Research Manager – FSP
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Job Description
Clinical Research Manager ensuring compliance and overseeing project management for clinical trials. Collaborating with various teams and responsible for study performance across countries.
Responsibilities:
- Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- For certain studies, could be responsible for several countries in a cluster.
- Responsible for project management of the assigned studies: Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and closeout.
- Leads local study teams to high performance: trains in the protocol for other local roles, collaborates with and supports Clinical Research Associates as protocol expert, coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), Clinical Research Associates (CRAs), and Clinical Operations Manager (COM).
- Responsible for creating and executing a local risk management plan for assigned studies
- Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies.
Requirements:
- 5-6 years of experience in clinical research; CRA experience preferred.
- Knowledge in Project Management/Site Management with proven strong project management skills and /or project management certification or relevant training program/close mentoring
- Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics as well as the ability to focus on multiple deliverables and protocols simultaneously
- Experience functioning as a key link between CO and CTT
- Proficiency in written and spoken English and local language; must be competent and effective in written and verbal communication
- Education/pedagogic, diplomatic, and empathetic skills to effectively build and maintain professional relationships with investigators and other external stakeholders.
- Travel expectations is up to 30% of working time
Benefits:
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
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