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Senior Clinical Trial Manager – Medical Device
Pharmavise Corporation. Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high performance, collaborative team environment.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high performance, collaborative team environment.
- Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements.
- Translate program strategy into operational plans, timelines, and resource needs; ensure cross functional alignment and timely delivery of study milestones.
- Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions.
- Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking.
- Lead proactive risk identification, mitigation planning, and contingency management across assigned studies.
- Provide clear, data driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies.
- Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts.
- Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success.
- Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations.
- Champion continuous improvement in clinical operations processes, tools, and best practices.
Requirements
What you’ll need- Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred.
- 10 years of experience in clinical research, including global clinical trials and vendor management.
- 5 years of demonstrated leadership experience managing and developing clinical trial staff, preferred.
- Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
- Proven ability to manage complex timelines, budgets, and cross ‑ functional deliverables.
- Excellent communication, negotiation, and stakeholder ‑ management skills.
- Ability to navigate ambiguity, drive decision ‑ making, and influence across levels of the organization.
- Proven exposure and experience to internal audits and regulatory body audits.
- Ability to work in fast-paced environment requiring support of multiple studies and direct reports simultaneously.
Benefits
Comp & perks- Contract Length: 8 Months
- Flexible work arrangements
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementbudget managementrisk identificationregulatory submissionsdata analysisvendor managementprotocol adherenceGCP complianceSOP adherencetimelines management
Soft Skills
leadershipmentoringcommunicationnegotiationstakeholder managementcollaborationproblem-solvingdecision-makinginfluenceadaptability