Clinical Trial Manager/Senior Clinical Trial Manager
New
F
Faeth TherapeuticsOncology, Biotech, Pharma
Remote (U.S.)Full-TimeManager
Salary not disclosed
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Job Details
- Experience
- 5+ years of clinical research experience within the biotech/pharma industry, 3+ years of oncology experience preferred
Requirements
- Bachelor's Degree is required
- 5+ years of clinical research experience within the biotech/pharma industry
- 3+ years of oncology experience preferred
- Knowledge of GCP
- Knowledge of ICH guidelines
- Knowledge of regulatory requirements for clinical trial management
- Experience in a small, fast-paced start up a plus
- Excellent communication skills
- Experience developing trial plans
- Experience with risk assessments/mitigation
- Experience tracking trial budgets
- Experience with site feasibility/selection
- Experience with clinical supplies management
- Clinical research knowledge
- Cross-functional understanding of clinical trial methodology
- Excellent organizational skills
- Conflict resolution skills
- Prioritization skills
- Proficient computer skills
Responsibilities
- Manage all aspects of assigned clinical trials, including, study vendor management and oversight.
- Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to project teams and leadership
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and SOPs
- Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, and other study level documents
- Lead site management, site engagement efforts, and coordinate streamlined site communications
- Facilitate cross-functional study team meetings and liaise with cross-functional areas for oversight of clinical study activities
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participates in vendor selection process as a part of outsourcing activities
- Proactively identify clinical trial issues, propose mitigations, and communicate as appropriate
- Responsible for assessing operational feasibility and contributing to operational plans
- Responsible for coordinating study-specific training of CRO study staff, monitors, investigational sites, and service providers, as appropriate
- In collaboration with legal group, facilitate the development of clinical trial related agreements and other relevant documents
- Support oversight of clinical trial budget, providing ongoing financial tracking including review of vendor invoices
- Coordinate data review process on an ongoing basis for data delivery
- Oversight of site visits including site qualification, initiation, monitoring and close-out visits, as needed
- Oversee monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues
- Ensure tracking and review of protocol deviations, including coordination to assess impact on study data
- Oversee work of junior Clinical Operations team members, as appropriate
- Support development and review of Clinical SOPs, department process improvements, and cross-functional initiatives
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