At a glanceSummarised by Seekless from the posting.
Must have28
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 data query process
Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines
Ensures 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
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
Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management
Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities
Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders
Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
Experience of data management and query resolution in clinical trials
Overall knowledge of site management and monitoring procedures
Nice to have1
Degree in the life sciences field preferred
When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Job Overview
The Clinical Trials Manager (CTM) will be a member of client’s Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.
Key Accountabilities:
Oversight of activities
•
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 (may include routine on-site clinical monitoring) 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; and assist in coordination of data management activities
•
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 data query process
•
Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines
•
Ensures trial master file is current and maintained
Collaborative relationships
•
Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.
Compliance with Parexel standards
Hiring process
•
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
Skills:
•
Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
•
Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
•
Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
•
Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders
Knowledge and Experience:
•
Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
•
Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
•
Experience of data management and query resolution in clinical trials
•
Overall knowledge of site management and monitoring procedures