Clinical Operations Onboarding Plan: Clinical Trial Manager
V1.0 July 10th, 2023
Instructions:
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The Clinical Trial Manager (CTM) will meet with their line manager to review the onboarding
plan and timeline outlined below.
CTM Line Manager will provide target due dates for each activity/training.
CTM to enter the date each onboarding activity/training is completed.
Onboarding activities must be completed within 4 weeks of the start date.
CTM Line Manager to review the completed checklist and sign-off once complete.
Name:
Line Manager:
Start Date:
Date Completed
Date Completed
Date Completed
Date Completed
SOPs (read and understood)
SOP-CD-001 SOP Development and Maintenance
SOP-CD-002 Oversight of a Contract Research Organization
SOP-CD-003 IP Shipment Release
SOP-CD-004 Clinical Development Training
SOP-CD-005 Investigational Product Temperature
Excursions
SOP-CD-006 Selection of Clinical Research Vendor and
Transfer of Obligations
Company and Administrative
Equipment Setup
Overview of Benefits - HR
Submit Updated CV to HR
Setup weekly onboarding check-ins with Line Manager
Company Overview and Structure – AD Clinical
Operations/Program Manager
Clinical Development
Overview of Clinical Programs – Program Manager
Review of Clinical Development Operations Files and
Systems – AD Clinical Operations
Review of Department and Organizational meetings – AD
Clinical Operations
Overview of Clinical Project Timeline and Smartsheet
Project Specific Training
Overview of Protocol and Study Timeline – Study Lead
Company Study System and File Access (SharePoint,
Smartsheet, Teams, etc.) – Study Lead
Molecule/Indication Training – Medical Monitor
Overview of Clinical Trackers - Study Lead
Clinical Trial Manager Onboarding Plan
Target Due Date
Week 1
Week 1
Week 1
Week 1
Week 1
Week 1
Target Due Date
Day 1-2
Day 1-2
Week 1
Week 1
Week 1
Target Due Date
Week 1
Week 1
Week 1
Week 1
Target Due Date
Week 1
Week 1
Week 2
Week 2
V1.0 July 10th, 2023
Date Completed
Overview of Vendors - Study Lead
Overview of Roles and Responsibilities - Study Lead
TMF Training – CRO
EDC Training – CRO
Study Specific System Access - CRO
Additional (as applicable)
Study Cross-training
Name:
Name:
Signature:
Signature:
Week 2
Week 2
Week 3
Week 3
Week 3
Target Due Date
X
X
New Employee
Clinical Trial Manager
Line Manager
Clinical Development Operations
Date of Signature:
Clinical Trial Manager Onboarding Plan
Date of Signature:
V1.0 July 10th, 2023