Junior Clinical Trial Manager
Parexel
full-time
Posted on:
Location Type: Remote
Location: Spain
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Job Level
About the role
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
- Provide guidance, direction, and management to CRAs
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
- Review Informed Consent Forms, CRFs, and study-related materials
- Plan and participate in investigator meetings
- Assist and support the data query process
- Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
- Ensure trial master file is current and maintained
- Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials
Requirements
- Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
- + 2 years experience in global project management as ACOL, Project Lead, Clinical Trial Lead, etc.
- Experience working with budgets
- Strong experience of data management and query resolution in clinical trials
- Overall knowledge of site management and monitoring procedures
- Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
Benefits
- Exceptional financial rewards
- Training and development
- Healthy work-life balance
- Flexibility and collaboration
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial documentationprotocol developmentdata managementquery resolutionmonitoring plansstudy materials designcontract negotiationpatient enrollment trackingregulatory complianceGood Clinical Practices (GCPs)
Soft Skills
project managementleadershipcommunicationcollaborationguidanceorganizational skills