Clinical Trial Manager - FSP
New
J
JobgetherClinical research
The position is remote in CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Required Skills
- Project Management
Requirements
- A degree in a life sciences field or a related discipline is preferred.
- Strong knowledge of Good Clinical Practice (GCP) and clinical research regulatory requirements, including applicable ICH and FDA guidelines.
- Experience managing clinical trials or clinical trial operations from initiation through closeout.
- Practical experience with protocols, CRFs, monitoring plans, informed consent documentation, and study manuals.
- Experience managing or working with CROs, external vendors, clinical sites, and clinical research partners.
- Knowledge of site management and clinical monitoring procedures, including site qualification, initiation, monitoring, and closeout.
- Experience with clinical data management processes and resolution of data queries.
- Strong project management skills, including managing timelines, budgets, risks, dependencies, and competing priorities.
- Strong problem-solving skills and ability to identify and resolve trial issues.
- Strong communication, organizational, and time-management abilities in a complex, multi-stakeholder clinical environment.
- Ability to collaborate while taking ownership of assigned studies and operational deliverables.
- Ability to complete required training, maintain accurate documentation, and support operational reporting.
Responsibilities
- Manage clinical trials and programs from study initiation through closeout.
- Manage external vendors and CROs to support trial execution.
- Prepare and maintain study manuals, monitoring plans, and other study documents.
- Coordinate the design and review of case report forms, patient diaries, participation cards, and source documents.
- Plan monitoring activities and oversee site qualification, initiation, monitoring, and closeout.
- Provide guidance and operational management to Clinical Research Associates.
- Track enrollment and coordinate clinical data management and data query resolution.
- Coordinate study supplies, vendor contracts, investigator meetings, and stakeholder communication.
- Maintain the Trial Master File and ensure sites follow GCP, SOPs, protocols, and applicable regulations.
- Identify and resolve operational issues while managing priorities, deadlines, and stakeholders.
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