Sr. Manager, Clinical Trial Lead

Kardigan•Princeton, NJ

9d•$166,000 - $216,000•Onsite

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company is seeking a Sr. Manager, Clinical Trial Lead to manage one of its cardiovascular clinical studies. This role is part of the Clinical Operations team, reporting to the asset’s Clinical Operations Program Leader (COPL). The Clinical Trial Lead (CTL) will be responsible for regional operational delivery in assigned countries/territories, ensuring key project deliverables are met according to budget, timelines, and quality standards. The overall goal is to develop new and innovative treatments for cardiovascular diseases with unmet needs. This position requires a 4-day onsite presence in Princeton, NJ, with potential consideration for South San Francisco.

Requirements

Minimum of BA/BS with approximately 8+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs.
Experience in early and late phase drug development; some late-stage development experience is required.
Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
Excellent communication skills, both verbal and written
Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.
Confidence to challenge status-quo thinking and behavior
Can work with agility and an innovative mindset.
Experience in ICH/GCP inspections, audits and inspection preparedness

Nice To Haves

Advanced degree preferred.
Experience within the field of cardiovascular studies and/or rare disease is desirable.
Experience in mentoring Clinical Operations staff

Responsibilities

Lead the planning, execution, and delivery of assigned clinical trials (global or regional scope).
Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report.
Serve as the primary operational point of contact for the cross-functional study team.
Align team execution with the study’s regulatory submission strategy and overall development plan.
Oversee site feasibility, selection, initiation, and activation; delegate to Clinical Trial Managers (CTMs) as appropriate.
Partner with CTMs to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout.
In partnership with the COPL, develop and execute participant recruitment strategies; review and approve operational plans, study manuals, and charters.
Lead operational strategy related to drug supply, remote monitoring, and decentralized trial processes.
Collaborate closely with the Clinical Development Lead on protocol development, amendments, and master ICFs.
Liaise with cross-functional team representatives to ensure cohesive trial execution.
Provide input into CRO and vendor selection, ensuring alignment with trial needs and operational strategy.
Direct and manage CRO and vendor partnerships, holding them accountable for timelines, quality, and budget commitments.
Drive management of CROs, vendors, and external partners through oversight, escalation, and proactive issue resolution.
Contribute to initial trial budget development and ongoing financial oversight.
Review and approve CRO/vendor work orders and change orders for accuracy and completeness.
Ensure compliance with ICH-GCP, local regulations, and company SOPs.
Oversee and coordinate the review of protocol deviations; manage amendments with cross-functional alignment.
Partner with Data Management to develop and approve data cleaning plans.
Maintain decision, action, and risk logs; escalate issues proactively and implement CAPAs when required.
Contribute to inspection readiness and support audits and regulatory inspections.
Coordinate responses to health authorities, ethics committees, and IRBs as needed.
Review and contribute to clinical study reports and regulatory filings.
May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g. contingent workers).
Provide coaching, feedback, and performance management to direct reports.
Support career development and training to build functional and leadership capabilities within the team.
Lead by example, fostering a collaborative and high-performance culture.