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