Senior Manager – Clinical Trial Liaison

atRegeneronRemoteUS flagUnited StatesFull-timeClinical ResearchSenior$134.4k – $219.2k/year

Posted 15 hours ago

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee daily operations for the delivery of specified therapeutic areas/projects within the Americas region as part of the Clinical Trial Liaison team.

• Supervise the performance of field-based CTLs and CTL personnel provided by external FSP vendors.

• Develop and implement a comprehensive operational strategy across the portfolio for designated therapeutic areas.

• Establish and nurture relationships with investigators and their site personnel.

• Identify prospective new investigators to facilitate optimal placement of clinical trials.

• Contribute insights in cross-functional discussions about study, program, and operational strategies.

• Conduct line management and performance supervision of assigned CTLs, including setting goals, deliverables, metrics, reviews, and development plans.

• Assist in resource planning and capacity assessments.

• Track FSP CTL performance against service-level agreements and escalate any issues.

• Ensure CTL delivery of study milestones, including feasibility, site identification and selection, patient recruitment, and retention.

• Recognize process enhancements and champion the CTL team.

• Maintain relationships with internal stakeholders and the external investigator community.

• Engage in remote and on-site co-visits with CTLs at investigator sites for coaching, oversight, and execution of clinical trials.

• Serve as the primary escalation point for internal study teams, sites, and CRO partners.

• Facilitate CTL participation in investigator meetings.

• Generate monthly performance reports for the Regional Head.

• Collaborate with Medical Affairs/Field Medical teams to assist CTLs in local meetings.

• Support CTLs during regulatory GCP inspections and/or audits as a sponsor representative.

• May dedicate up to 15% of time as a CTL on studies and with sites.

• Assist in onboarding, identify training needs, and ensure uniform role, study, systems, and compliance training across CTLs.


⛳️ Requirements

• A minimum of a Bachelor's degree.

• A Master's/Ph.D./PharmD. degree is preferred.

• At least 8 years of relevant industry and/or CRO experience in clinical trial operations.

• A minimum of 3 years in a people management role with direct line management responsibilities.

• Proven experience in line and performance management, including formal performance evaluations and development planning.

• Extensive background in global clinical trial operations.

• A proven track record of managing and developing field-based teams.

• In-depth scientific knowledge and understanding of the clinical development process, including ICH GCP and regional regulatory requirements.

• Exceptional ability to communicate technical and scientific information effectively.

• Strong interpersonal skills with a collaborative and independent working style.

• Capacity to build productive relationships with principal investigators and site personnel.

• Excellent organizational skills with effective time management and prioritization.

• Awareness of cross-cultural dynamics.

• Proficiency in Business English.

• Strong operational experience as a Clinical Trial Liaison with consistently excellent performance metrics.

• Experience in coaching and mentoring.


🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company matching.

• Health and wellness initiatives.

• Access to fitness centers.

• Medical, dental, vision, life, and disability insurance coverage.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process when needed.

• An inclusive workplace culture.

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