Clinical Trial Liaison Manager

3 weeks ago

Princeton, United States BESTMSLs Full time

Clinical Trial Liaison Manager

US-NJ-Princeton

Job ID: 2024-1879
# of Openings: 1
Category: Clinical Trial Liaison
BESTMSLs

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 the company 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 Medical and Clinical organization and ensures compliance with project plans, regulatory requirements, GCP, SOPs, and company policies.

Responsibilities

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:

  1. Site and Investigator Relationship Management

    • Acts as an ambassador for the company, 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.

  2. Patient Recruitment and Enrollment

    • 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.

  3. Monitoring and Compliance

    • 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).

  4. Collaboration and Best Practices Sharing

    • 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.

  5. Audits, Inspections, and Quality Assurance

    • 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.


Qualifications

Education and Experience

  • Bachelor’s degree required, preferably in the life/physical sciences.
  • Nursing or PharmD preferred but not mandatory.
  • Strong scientific background with at least five years of clinical development experience.
  • 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 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.

Location/Travel

  • This position is located at the 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%); occasional international travel.

PI5f40df4db949-30169-36004730

  • Clinical Liaison Manager for Clinical Trials

    1 week ago

    Princeton, New Jersey, United States BESTMSLs Full time

    Job Title: Clinical Trial Liaison ManagerThe Clinical Trial Liaison Manager is a key position at BESTMSLs, responsible for overseeing site trial delivery, subject recruitment, protocol adherence, and data quality. This hybrid office-based role requires regular travel in the field.Responsibilities:Site and Investigator Relationship ManagementRepresent the...

  • Senior Clinical Trial Manager

    6 months ago

    Princeton, United States Genmab Full time

    At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Clinical Services Manager

    1 month ago

    Princeton, New Jersey, United States WCG Clinical Full time

    About WCG ClinicalWCG Clinical is a leading provider of clinical solutions, built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials.Job SummaryThe Manager, Clinician Services is responsible for managing the...

  • R&D Quality Assurance Associate-Clinical Trial

    7 days ago

    Princeton, United States SPECTRAFORCE Full time

    Job Title: R&D Quality Assurance Associate-Clinical TrialLocation: Princeton, NJ- 08540Duration: 12 Months (Possibility of Extension) Position SummaryThis role will work closely with the other team members in Quality Risk & Compliance (QRC) to assist in assessment, reporting on compliance and improvement of processes, tools and systems for Client's clinical...

  • Senior Manager, Clinical Outsourcing

    1 month ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across...

  • Sr. Manager, Clinical Research Scientist

    2 weeks ago

    princeton, United States Real Staffing Group Full time

    Position Summary:The Senior Manager, Clinical Research Scientist assists in designing, executing, and reporting Phase 1-3 clinical oncology trials. The role supports the medical monitor with key tasks related to trial design, conduct, monitoring, analysis, and reporting.Performance Objectives:Collaborate with team members (Medical Monitors, Project Managers,...

  • Senior Manager, Clinical Outsourcing

    1 month ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Description Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100...

  • Senior Manager, Clinical Outsourcing

    4 weeks ago

    Princeton, United States Sun Pharmaceutical Industries Full time

    Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world's fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the...

  • Senior Manager, Clinical Outsourcing

    4 weeks ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world's fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the...

  • Senior Manager, Clinical Outsourcing

    2 months ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

     Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across...

  • Senior Manager, Clinical Outsourcing

    1 month ago

    PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full time

     Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across...

  • Clinical Development Liaison

    3 weeks ago

    Princeton, New Jersey, United States Gardner Resources Consulting Full time

    Job Title: Medical Science LiaisonAbout the Role:We are seeking a highly skilled Medical Science Liaison to join our team at Gardner Resources Consulting. As a Medical Science Liaison, you will play a critical role in engaging with healthcare partners and providers, communicating strategic objectives, and educating stakeholders on the value and outcomes of...

  • Senior Director, Clinical Scientist, Oncology

    2 months ago

    Princeton, United States PMV Pharmaceuticals, Inc. Full time

    Senior Director, Clinical Scientist, OncologyThe Senior Director, Clinical Scientist, Oncology will lead the scientific planning and execution of clinical trials for our oncology assets including development of clinical trial designs and data interpretation. This role involves strategic oversight and hands-on management of clinical studies ensuring alignment...

  • Senior Manager, Clinical Outsourcing

    1 month ago

    PRINCETON, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

     Title: Senior Manager, Clinical Outsourcing Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across...

  • Clinical Data Analyst

    7 days ago

    Princeton, United States Net2Source Inc. Full time

    Title: R&D Quality Assurance Senior Associate IILocation: Princeton, NJ 08648 or San Diego, CA 92130Duration: 12+ Months (Extendable)Pay Rate: $46.00/hr on W2Must Have: Clinical studies or drug safety Pharma/research development is highly preferred Data analytics/ data visualization experience is requiredProject management – Nice to have The previous...

  • Clinical Data Scientist

    1 week ago

    Princeton, United States Otsuka Full time

    br> Work alongside statisticians and data management to perform in-depth exploration of raw data collected from various sources, such as clinical trials, real-world, and public domain data. Guide evidence-based product development by extracting therapeutic intelligence from such data sources. Use strong programming skills for data analysis involving...

  • Associate Vice President, Clinical Development

    2 months ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

    Assistant Vice President, Clinical Development Group Lead Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare...

  • Executive Director, Clinical Development

    4 weeks ago

    Princeton, United States The Carolan Group Full time

    Job Title: Executive Director, Clinical Development (Oncology)Location: Princeton, NJReports To: Chief Medical Officer / Senior Vice President of Clinical DevelopmentPosition Summary:The Executive Director of Clinical Development in Oncology will lead clinical strategy and operations for a robust oncology portfolio. This role is responsible for overseeing...

  • Senior Manager, Clinical Outsourcing Lead

    1 month ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Manager, Clinical OutsourcingJob Summary:Sun Pharmaceutical Industries, Inc. is seeking a Senior Manager, Clinical Outsourcing to lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for Sun Pharmaceutical's clinical development programs.Key...

  • Associate Vice President, Clinical Development

    1 month ago

    Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

     Apply (by clicking the relevant button) after checking through all the related job information below. Assistant Vice President, Clinical Development Group Lead Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Supported by more...