Sr. Manager, Clinical Trial Lead

Kardigan•Princeton, NJ

7d•$166,000 - $216,000•Onsite

About The Position

Kardigan is seeking a Sr. Manager, Clinical Trial Lead to manage a cardiovascular clinical study as part of the Clinical Operations team. The role reports to the asset’s Clinical Operations Program Leader (COPL) and is specifically for a regional Clinical Trial Lead, driving operational delivery in assigned countries or territories. The CTL ensures project deliverables meet budget, timelines, and quality standards defined by regulations, company SOPs, and ICH-GCP, supporting the development of treatments for cardiovascular diseases with unmet need. This position is four days onsite in Princeton, New Jersey; onsite work in South San Francisco may also be considered. The role leads trial planning, execution, and delivery from synopsis through Clinical Study Report, serving as the primary operational contact for the cross-functional study team. It oversees study start-up, site and vendor readiness, participant recruitment strategies, operational plans, drug supply, remote monitoring, and decentralized trial processes. The CTL also manages vendor relationships, contributes to budget and resource oversight, ensures quality and regulatory compliance, coordinates reporting and documentation, and may manage and develop Clinical Operations staff.

Requirements

Minimum of a BA/BS degree.
Approximately 8 or more years of experience in global clinical trial management roles at pharmaceutical companies and/or CROs.
Experience in early- and late-phase drug development, including some late-stage development experience.
Multidimensional Clinical Operations experience and the ability to devise plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol-deviation management, and data cleaning.
Excellent verbal and written communication skills.
Demonstrated ability to lead and collaborate with cross-functional teams to drive operational excellence.
Ability to challenge status-quo thinking and behavior.
Ability to work with agility and an innovative mindset.
Experience with ICH/GCP inspections, audits, and inspection preparedness.
Experience mentoring Clinical Operations staff.

Nice To Haves

Advanced degree preferred.
Experience in cardiovascular studies and/or rare disease is desirable.

Responsibilities

Lead the planning, execution, and delivery of assigned clinical trials, with regional scope for this position.
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, delegating to Clinical Trial Managers as appropriate.
Partner with Clinical Trial Managers to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout.
Partner with the COPL to 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 with the Clinical Development Lead on protocol development, amendments, and master informed consent forms.
Liaise with cross-functional team representatives to support cohesive trial execution.
Provide input into CRO and vendor selection and manage CRO and vendor partnerships against timeline, quality, and budget commitments.
Oversee CROs, vendors, and external partners, including escalation and proactive issue resolution.
Contribute to 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 protocol-deviation reviews and manage amendments with cross-functional alignment.
Partner with Data Management to develop and approve data-cleaning plans.
Maintain decision, action, and risk logs; proactively escalate issues 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 manage Clinical Trial Associates, Clinical Trial Managers, or other assigned staff, including contingent workers.
Coach, provide feedback, and manage performance of direct reports; support career development and training.
Lead by example and foster a collaborative, high-performance culture.