Clinical Trial Liaison Manager

Overview

The Clinical Trial Liaison Manager (CTLM) is a Hybrid office-based position with regular travel in the field. The role is based in North America, overseeing site trial delivery, subject recruitment, protocol adherence, and data quality. The CTLM represents RRD in site relations, supports study teams with startup and recruitment, and manages in-field activities of the contracted CRO, focusing on the CRA team. The CTLM also addresses unresolved investigator concerns, engages with PIs for study updates and recruitment plans, and supports local site staff and trial team members. Additionally, the role provides project management support across the Clinical organization and ensures compliance with project plans, regulatory requirements, GCP, SOPs, and company policies.

Essential Duties and Responsibilities

• Contributes to operational trial deliverables at clinical trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards. Assigned key responsibilities include:

  • Site and Investigator Relationship Management
  • Patient Recruitment and Enrollment
  • Monitoring and Compliance
  • Collaboration and Best Practices Sharing
  • Audits, Inspections, and Quality Assurance

Education and Experience

• Bachelor’s degree required, preferably in the life/physical sciences

• Strong scientific background with at least five years of clinical development experience in oncology

• Extensive clinical development and pharmaceutical experience with a good knowledge of the applicable regulations in order to have a thorough understanding of the processes associated with executing clinical development plans

• Experience working on audits, regulatory inspections, and CAPAs

• Experience working on Phase 1-4 clinical development studies

• Highly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases.

Knowledge and Skills

• Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials

• Strong written and verbal English communication and presentation skills

• Extensive knowledge of GCP regulations, CFR, and ICH Guidelines

• Skilled at conflict resolution, collaborating with stakeholders with varying viewpoints, influencing with and without authority, and negotiation. Includes relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs (Patient Advocacy Groups), CROs and others.

Work Environment

This job operates in a professional office environment. Based upon job requirements, employee may be required at times to attend meetings including travel out of province over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver's license and passport.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via a commercial air carrier. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; reach with hands and arms; and talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• This position is located at RRD HQ Office in Bridgewater, New Jersey with an average of 3 days per week in the office expected

• The position requires domestic travel (up to ~40%); possible occasional international travel

FLSA Classification

This position is considered Exempt.

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, provincial, or municipal law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.