Clinical Trial Liaison

Recordati•Bridgewater, NJ

60d•Hybrid

About The Position

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati. At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do. What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference. Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution. 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.

Requirements

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
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.

Nice To Haves

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
Working with rare diseases

Responsibilities

Acts as an ambassador for RRD, supporting its positioning as a sponsor of choice, and representing the sponsor with investigators and site staff
Drives enrollment at the principal investigator (PI) level, collaborating closely with clinical research associates (CRAs) and study coordinators
Facilitates collaboration between departments or groups within the same trial site to optimize subject enrollment
Maintains accountability for long-term operational partnerships with key sites, providing local intelligence
Leads strategic partnerships with key sites to implement collaborative initiatives for clinical trial execution
Oversees and tracks patient recruitment for sites, proactively identifying ways to prevent delays
Supports the development of recruitment and retention plans in collaboration with Lead CSM, CSM vendor/CRO, or Local CSM
Conducts motivational or booster visits upon request by the sponsor
Reports local site situations and provides insights on recruitment challenges and solutions
Ensures data quality and integrity meet Good Clinical Practice (GCP) standards and local regulations through data reviews (remote and onsite)
Oversees the activities of local CRO teams to ensure effective sponsor oversight of monitoring activities
Conducts Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring, including source data verification (SDV) as needed. Accurately creates and documents progress in clinical trial monitoring system and follows up on open issues through resolution
May attend pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs)
Identifies trial issues proactively, seeks solutions, and escalates them to the appropriate authorities (Lead CSM, CSM vendor/CRO, or Local CSM)
Collaborates with other CTLMs, Lead CSM, CSM vendor/CRO, or Local CSM to share best practices and beneficial experiences
Supports CRAs and local CRO team members to aid trial delivery and compliance
May assist with quality assurance, audit and inspection preparations, including generating and implementing Corrective and Preventive Action (CAPA) plans
May attend audits and inspections as required
Adheres to company SOPs