Senior Clinical Trial Manager
New
P
Precision Medicine GroupClinical trials
Remote, Brazil; Remote, Colombia; Remote, MexicoFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- Professional working proficiency in English required
- Experience
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Required Skills
- Microsoft OfficeRisk Management
Requirements
- Hold a bachelor’s degree, or an equivalent combination of education and experience, in a science or health-related field.
- Have at least 7 years of clinical research experience or proven competencies for the position, including significant clinical monitoring experience.
- Have professional working proficiency in English.
- Have experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
- Be able to travel domestically and internationally, including overnight stays.
- Demonstrate mastery of ICH-GCP, relevant SOPs, and regulatory guidance.
- Have working knowledge of clinical management techniques and tools.
- Have direct experience working in a cross-functional environment.
- Have experience in functional management, delegation, planning, risk management, and change management.
- Have in-depth experience in pharmaceutical and/or device research.
- Demonstrate negotiation, conflict management, analytical, and decision-making skills.
Responsibilities
- Serve as the primary clinical point of contact for clients and collaborate with project managers on clinical budgets and resourcing.
- Develop study clinical documents, training materials, and training plans for CRAs and third-party vendors.
- Generate potential site lists, lead site feasibility, and develop country recruitment and retention strategies.
- Coordinate communication with investigators and study teams throughout feasibility, site start-up, enrollment, maintenance, and closeout.
- Lead internal clinical team meetings and set expectations for CRAs and CTAs.
- Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees with regulatory departments.
- Develop clinical monitoring strategies and use study metrics to track timelines, quality, and issues.
- Implement and manage the eTMF, and collaborate with project managers, CRAs, and QA on CAPA plans and closure.
- Support GCP audit preparation, data quality, investigational product processes, and site budget or investigator contract negotiations as applicable.
- Manage clinical vendors and assume project management responsibilities when a cross-functional PM is not assigned.
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