Clinical Research Project Manager – Study Start-Up
New
U
UniTriTeam (UTT)Clinical research
Location: Mexico City. Mexico; Location: Remote / Client-Specific Requirements, PST/EST/CST TimezoneFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Minimum 3–5 years of experience in clinical research
- Required Skills
- Project ManagementMicrosoft Excel
Requirements
- Bachelor’s degree in life sciences, healthcare administration, clinical research, or a related field; equivalent relevant experience may be considered.
- Minimum 3–5 years of experience in clinical research, preferably in clinical trial operations, site operations, or study start-up.
- Demonstrated experience managing clinical research projects, study start-up activities, or site activation processes.
- Strong understanding of the clinical trial lifecycle, including feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.
- Experience coordinating multiple functional departments and managing interdependent deliverables.
- Knowledge of Good Clinical Practice (GCP), clinical research regulations, and standard operating procedures.
- Proficiency with project management tools, trackers, Microsoft Excel, and collaborative platforms.
- Ability to manage multiple studies or projects simultaneously while maintaining accuracy and meeting deadlines.
- Experience within a clinical research site, site network, SMO, CRO, or sponsor organization is preferred.
- Familiarity with CTMS, eRegulatory, eSource, and EDC platforms is preferred.
- PMP, ACRP, SOCRA, or another relevant professional certification is preferred.
Responsibilities
- Own study start-up from initial study award or feasibility through site activation and readiness for first patient enrollment.
- Develop study start-up plans, timelines, milestones, and deliverables.
- Coordinate start-up activities across regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, sponsors, CROs, vendors, and site leadership.
- Track feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements.
- Lead start-up meetings, assign action items and owners, and follow up on commitments.
- Build and maintain project plans, start-up trackers, and centralized records of decisions, risks, action items, and dependencies.
- Monitor milestones and deliverables, identify delays and bottlenecks, and implement mitigation or recovery plans.
- Provide timely status updates and escalate risks and unresolved issues to leadership and stakeholders.
- Coordinate operational readiness, including staffing, training, supplies, systems, and required documentation.
- Verify readiness of applicable CTMS, eRegulatory, eSource, EDC, and study-specific systems.
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