Clinical Trial Manager
Bristol Myers Squibb
3 months ago
Remote friendly (Lawrence, NJ)
United States
Clinical Research and Development
Position: Clinical Trial Manager (CTM)
Responsibilities:
- Oversee end-to-end study operations at country level to meet timelines, budget, and quality.
- Act as country primary point of contact for internal/external stakeholders; ensure clear communication and coordination.
- Lead country/site feasibility and proposal/validation of country study targets.
- Plan and execute start-up timelines/activities with local study team, GTAC, and stakeholders.
- Implement patient recruitment strategy and risk mitigation; ensure enrolment targets/timelines.
- Lead issue/risk resolution, including contingencies and appropriate escalation.
- Set up local vendors during start-up; participate in investigator meetings.
- Ensure CTMS data is current/complete; ensure eDC/eTMF/eTMF access; upload documents in eTMF.
- Validate study materials (protocol, ICF, patient materials) and support document reviews/prep.
- Support Site Initiation Visits/Investigator Site Assessment Visits; verify eTMF completeness.
- Acknowledge monitor visit reports, act within timelines, and document/escalate issues.
- Coordinate database locks and query follow-up; ensure timelines.
- Ensure inspection readiness; support Health Authority inspections.
- Coordinate CAPA for country audit findings.
- Coordinate local study team meetings; support GTAC with invoice queries/patient compensation claims (if applicable).
- Support site relationship management (including CRO issues), possible site closure, and serve as point of contact for sites.
- Prepare/support Health Authority and Ethics Committee submissions and follow-up to approval (as required).
- Support approvals for closure of funds/POs; update national registries (if applicable).
- Coordinate resources on evolving country regulatory requirements with Regulatory/Legal.
Competencies/Skills:
- GCP, ICH guidelines, and local clinical research regulations/codes of practice.
- Clinical research processes, regulations, methodology; understanding of medical settings and medical records management.
- Strong planning/organizational skills; independent decision-making.
- Communication skills (oral/written) influencing others; English and local language.
- Proficient independently in Microsoft Suite, CTMS, eDC, eTMF.
Qualifications:
- Bachelor’s or Master’s in life sciences or equivalent.
- Minimum 4 years industry experience.
- Experience leading/participating in cross-functional teams and initiatives.
- Occasional local travel < 1 month/quarter.
Benefits (as listed): Health coverage (medical/pharmacy/dental/vision), wellbeing support (including EAP), financial protection (401(k), disability, life/accident insurance, legal support, survivor support), and paid time off programs.
Responsibilities:
- Oversee end-to-end study operations at country level to meet timelines, budget, and quality.
- Act as country primary point of contact for internal/external stakeholders; ensure clear communication and coordination.
- Lead country/site feasibility and proposal/validation of country study targets.
- Plan and execute start-up timelines/activities with local study team, GTAC, and stakeholders.
- Implement patient recruitment strategy and risk mitigation; ensure enrolment targets/timelines.
- Lead issue/risk resolution, including contingencies and appropriate escalation.
- Set up local vendors during start-up; participate in investigator meetings.
- Ensure CTMS data is current/complete; ensure eDC/eTMF/eTMF access; upload documents in eTMF.
- Validate study materials (protocol, ICF, patient materials) and support document reviews/prep.
- Support Site Initiation Visits/Investigator Site Assessment Visits; verify eTMF completeness.
- Acknowledge monitor visit reports, act within timelines, and document/escalate issues.
- Coordinate database locks and query follow-up; ensure timelines.
- Ensure inspection readiness; support Health Authority inspections.
- Coordinate CAPA for country audit findings.
- Coordinate local study team meetings; support GTAC with invoice queries/patient compensation claims (if applicable).
- Support site relationship management (including CRO issues), possible site closure, and serve as point of contact for sites.
- Prepare/support Health Authority and Ethics Committee submissions and follow-up to approval (as required).
- Support approvals for closure of funds/POs; update national registries (if applicable).
- Coordinate resources on evolving country regulatory requirements with Regulatory/Legal.
Competencies/Skills:
- GCP, ICH guidelines, and local clinical research regulations/codes of practice.
- Clinical research processes, regulations, methodology; understanding of medical settings and medical records management.
- Strong planning/organizational skills; independent decision-making.
- Communication skills (oral/written) influencing others; English and local language.
- Proficient independently in Microsoft Suite, CTMS, eDC, eTMF.
Qualifications:
- Bachelor’s or Master’s in life sciences or equivalent.
- Minimum 4 years industry experience.
- Experience leading/participating in cross-functional teams and initiatives.
- Occasional local travel < 1 month/quarter.
Benefits (as listed): Health coverage (medical/pharmacy/dental/vision), wellbeing support (including EAP), financial protection (401(k), disability, life/accident insurance, legal support, survivor support), and paid time off programs.