Job Overview

• Responsible for oversight of third-party laboratory (TPL) services on all studies for a designated customer or customers across each phase and aspect of delivery:

  • Governance – routine meeting to provide oversight across all phases of delivery and reporting on general status/progress of key activities, systemic issues, risks and mitigations, lessons learned, etc.

  • Early Engagement – pre-award / proposal phase of opportunities where new TPLs may need to contracted and/or qualified and specialty tests at in-network TPLs may need to be reviewed prior to first-time use

  • Study Setup – post-award setup phase where TPL testing is configured, study-level contracting is executed, and the data flow between the TPL and IQVIA Laboratories (IQL) is defined

  • Study Maintenance – study has launched and is in the execution phase where oversight of samples routed to TPLs and their results are critical in addition to managing any study escalations and resolving issues relating to the TPL delivery.

  • Study Closeout - final phase of study execution prior to database lock where support to close out all open data queries and obtain final data transmissions will be required.
    

• Governance

  • Acts as primary LNS contact with Operation Client Lead (OCL) on the governance of external labs in use on studies

  • Attends Strategic and Operational governance meetings with labs used on studies

    • Monitors TPL performance metrics

    • Prepares TPL portfolio dashboard

  • Attends governance meetings, and:

    • Reports on status of any labs in MSA contract negotiations and/or qualification

    • Reviews critical and major findings from initial qualification audits and periodic reviews to inform decision-making on qualification approval or continued use for the customer

    • Shares advice to the Sponsor if the requested external Laboratory is found not fit for purpose.

    • Shares dashboard on TPL in use on studies

    • Answers any questions at a study level on setup progress, TATs, samples, results, etc.

    • Creates and maintains risk/issue log with mitigations across portfolio

  • Identifies process improvements and new services needed to support portfolio

  • Oversees development and implementation of new services and process improvements
    

• Early Engagement

  • Collaborates with LNS Alliance Managers on contracting and/or qualifying new labs for use on studies

    • Initiates the Qualification Process and Confidentiality Disclosure Agreement (CDA) request for new external lab, where required.

    • Initiates MSA request with Drive MSA negotiations and coordinate with Legal as needed

    • Collaborates with LNS Quality Assurance Manager for the planning, conduct and reporting of audits

    • Attends close out meetings and discuss findings with LNS QA Manager

    • Shares the audit report with the Sponsor during Governance or upon request

    • Updates the LNS central repository with relevant information.

  • Engages Scientific Support Team (SST) to assess the Regulatory status of assay when requested to report directly to sites

  • Attends weekly LNS Team calls and share updates on labs in use

    • Shares status with LNS team and SST of new labs under contract/qualification for

    • Facilitates LNS team call occasionally based on team ROTA

  • Logs any risks into risk/issue log and identify mitigations

• Study Setup

  • Attends Internal Study Review (ISR) meeting for studies with TPL testing in scope

  • Supports Study PM and LNS Lead assigned to studies with TPL testing in scope

  • Monitors studies in portfolio with TPL testing in scope and prepares progress report for governance

  • Acts as first line of escalation support to LNS Leads and Study Project Managers on studies

  • Oversees QIs involving the TPL to closure and acts as the internal CAPA Owner.

  • Logs any risks into risk/issue log and identify mitigations
    

• Study Maintenance

  • Leverages various tools to provide oversight of samples routed to TPLs and their results by study

  • Manages any study escalations and resolving issues relating to the TPL delivery.

  • Logs any risks into risk/issue log and identify mitigations
    

• Study Closeout

  • Provides support to close out all open data queries and obtain final data transmissions as appropriate

  • Participates in study team lessons learned

  • Updates risk/issue log as needed

  • Ensures all study documentation is filed appropriately.

Skills

• Possess strong interpersonal skills for interaction with senior members within sponsor organizations and demonstrated ability to meet deadlines.

• Experience in successfully working on and delivering clinical trials.

• Experience with vendor management and strong relationship management skills

• Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.

• Demonstrated computer proficiency with Microsoft Office and IQL’s business systems.

• Possess an understanding of medical and clinical research terminology.

• High degree of emotional intelligence.

• Strong problem-solving skills.

• Proven conflict-resolution and management skills.

• Productive time-management skills as role is home-based.

• Demonstrated ability to work in a fast-paced, high stress environment.

• Previous knowledge of IQL processes and computer systems is highly desired.

• Easily builds productive relationships and knowledge of customer’s expectations and preferences

• Good organizational and operational skills

• Good accuracy and attention to detail skills

• Strong written and verbal communication skills including good command of English language

• Proven conflict-resolution and management skills.

• Productive time-management skills as role is home-based.

Qualifications

• Bachelor's degree in science related field and extensive experience within the clinical or research industry experience, including project management or coordination experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech

• Extensive use of keyboard requiring repetitive motion of fingers

• Regular sitting for extended periods of time

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com