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Kardigan · 1 day ago

Sr. Manager, Clinical Trial Lead

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$157K/yr - $205K/yr

10+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. They are seeking a Sr. Manager, Clinical Trial Lead to manage cardiovascular clinical studies, ensuring project deliverables are met according to budget, timelines, and quality standards.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

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

Qualification

Clinical trial managementCardiovascular studiesDrug developmentICH-GCP complianceVendor managementBudget managementAgilityCommunication skillsLeadershipCollaboration

Required

Minimum of BA/BS with approximately 10 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

Experience in mentoring Clinical Operations staff