-BS Degree and 10+ years of Clinical Trials/Research experience
-5+ years of Managing Clinical Trials
-Renal denervation
-Clinical Trial Execution
-Clinical trial management
-People management of clinical trials
-Cardiology Clinical trials
Required Qualifications
- 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
Job Purpose
The Senior Manager, Clinical Trials provides strategic and operational leadership to Clinical Trial Managers and associated study staff in support of global clinical programs. This role is accountable for the planning, execution, and oversight of RDN clinical trials, ensuring alignment with program strategy, timelines, budgets, quality standards, and regulatory requirements. The Senior Manager drives clinical excellence across studies, oversees vendor performance, and ensures audit readiness throughout the lifecycle of each trial.
Key Responsibilities
- 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.
#GRPA
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
Job Types: Contract, Full-time
Pay: $60.00 - $90.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
