Laboratory Project Services Manager

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.Job Family DescriptionDevelops, plans, manages and reports on laboratory projects and project progress or developments and ensures outcomes arealigned with client expectations.Sub-Family DescriptionManages the delivery of clinical research studies from initiation to closeout.Ensures quality deliverables are presented on time and within budget; coordinates work streams and efforts of cross-functionalproject teams; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point ofcontact with the project sponsor.JOB OVERVIEWJob Profile SummaryUnder general direction, manage all laboratory aspects of clinical trial projects for a client ora specific program for a client; May have responsibility for a specific client, drug program,indication or drug compound; Act as main point of contact for the client after study awardand throughout the entire study lifecycle (startup, maintenance, closeout). Roleencompasses Project Lab Services Manager and Associate Lab Services Project ManagerResponsibilitiesEssential FunctionsStudy Setup and Planning a. Manage individual clinical trial projects as assigned. b. Facilitate Seamless Study Set-Up: i.Review study protocol and bid/budget information once a study is awarded. ii. Ensure initial meetings are conducted (e.g.document review meetings, Design, and/or Startup meetings) with sponsor to ensure client Protocol requirements areunderstood and applied to the design of the lab study as well as to relay lab processes to the client. iii. Consult and advisecustomer on best or most proper course of action as needed. iv. Develop, relay and implement the Project Management Planand Risk Management Plan per study as applicable; Create cost containment measures. v. Partner with Study Set-Up team toensure quality of study set-up. c. Participate in the proposal development process as applicable. d. Participate in the businessdevelopment processes as applicable to Project Services responsibilities. e. Lead in the development of sponsor specificstandards and/or program-specific procedures. f. Ensure key milestones are met and appropriate resources are available. g.Oversee the writing of protocol-specific laboratory instructional materials (e.g. manuals, flowcharts, etc.) and participate in thepreparation and maintenance of the laboratory specification documents. h. Support the development of sponsor specificstandards and/or program-specific procedures.Study Activity Monitoring and Closeout a. Monitor Project Management Plan, timelines, and deliverables, including trendanalysis of study specific data, budget and change orders. b. Manage study scope changes and study budget. c. Utilizeavailable tools, metrics, and reports as part of global study monitoring and closeout. d. Manage all service related issues andimplement changes to plan as required. e. Conduct meetings with internal departments as required to meet needs of studyand closeout activities. f. Monitor quality of study and proactively determine and implement solutions for any issues that arise.g. Report study progress to internal and external clients. h. Ensure lessons learned are considered, shared and improvementsincluded in processes as applicable.Proactive lines of communication a. Build and own client relationship for assigned study and serve as a liaison betweenSponsor and project teams. b. Facilitate Communication with the Client. i. Act as the single point of contact for client, bothresponding and triaging communications. ii. Lead and/or participate in key client facing meetings (investigator meetings, studyResponsibilitiesEssential Functionsmeetings, etc.). c. Coordinate customer survey follow-up / ongoing health check calls and overall client relationship building.d. Lead problem solving and resolution efforts in a timely, client-focused manner. e. Collaborate with other functional groupswithin the company where necessary to support milestone achievement and to manage study issues and obstacles. f. Serveas a point of escalation for program level issues, while ensuring consistency of delivery on a global level. g. Coordinate andTriage Study-specific issues.i. Lead in the identification and resolution of service level issues and where issues affect other projects within and acrossprograms to ensure that any solution is employed universally. Develop proactive contingency plans to mitigate laboratory risk.ii. Escalate issues that impact the study plan or budget and relay any issues or trends to clients as applicable. iii. Facilitateregular review meetings to discuss proactive problem resolution of study specific issues, utilizing the necessary resourcesfrom all relevant internal departments.Project Documentation and Deliverables a. Coordinate meeting agenda, document minutes, track actions, and provide statusupdates. b. Oversee the writing of protocol-specific laboratory instructional documents (e.g. manuals, flowcharts) andparticipate in the preparation and maintenance of the laboratory specifications document for each assigned protocol. c.Develop start-up plans including but not limited to a program/project monitoring and communication plan, including tracking ofmilestones and timelines, risk management and action logs. As required, prepare and present study-specific materials andservices at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnelas required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).Participate in Investigator Meetings and Training Activities a. Represent the company at Investigator/ Monitor meetings,internal and external authorities of regulatory bodies, and other Face to face meetings. b. Participate in external and internalaudits/inspections as required. c. As needed, administer study training to sites, CRA and sponsors and establish regular linesof communication with sites to manage on-going project expectations and issues. d. All associates will be familiar with thesafety, environmental rules and procedures applying to their job and take reasonable care for their own safety and that ofother people. Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listedbelow are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enableindividuals with disabilities to perform the essential functions.ExperienceTypically requires 2 - 3 years of prior relevant experience.KnowledgeRequires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advancededucation combined with experience.EducationEducation Level Education Details Req PrefBachelor's Degree Life Sciences and/or related field preferred XAdditional Work ExperienceExperience Details Req Pref1-3 years of experience in clinical trials/ hospital-funded research, project management or laboratoryenvironment preferred. X OrEquivalent combination of education, training and experience XSkills and AbilitiesSkill/Ability Description ProficiencyEffective interpersonal skills Strong interpersonal and client management skillsPossesses strong product knowledge Working understanding of medical and clinicalresearch terminology.Project Demonstrated project management skills Working knowledge of Project Managementprocesses, the company laboratory processes, and/orequivalent working knowledge of central laboratoryoperations (kits/supplies, logistics, laboratoryoperations, specimen storage, data reporting andtransfers, site alerts, etc.) preferred.Possesses strong technical aptitude Demonstrated computer proficiency with MicrosoftOffice and the company systems, or equivalentSkills and AbilitiesSkill/Ability Description Proficiencyexperience with similar Centralized Laboratorysystems preferred.Possesses strong product knowledge Experience in successfully leading Phase I-IV clinicaltrials preferred.Maintains composure under pressure Demonstrated ability to work in a fast-paced whilepossessing strong organizational skills and ademonstrated ability to meet deadlines.Strong verbal communication and listening skills Strong written and verbal communication skillsincluding good command of English language. Incertain geographies where communication in locallanguage is desired (e.g. Japan, China), excellentcommand of local language with reasonableproficiency in English preferred.Ability to build strong customer relationships Ability to establish and maintain effective workingrelationships with coworkers, managers and clients.Standard ADA SettingsThe physical demands described here are representative of those that must be met by an employee to successfully perform theessential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform theessential functionsStandard ADA Selection Office EnvironmentPhysical DemandsPhysical Demand N/A Rarely Occasionally Frequently ConstantlySit at a desk or table with somewalking, standing, bending, stooping,or carrying of light objects.XUse hands and fingers to handle andmanipulate objects and/or operateequipment.XWorking EnvironmentWhile performing the duties of this job, the associate is required to meet the following physical demands:Working Condition N/A Yes NoWorking Indoors XUse of Office Equipment (computer,printer, telephone, etc.) XTravel RequirementsFrequency Brief DescriptionMay require occasional travelIQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workdayrecruiting@iqvia.com to arrange for such an accommodation.At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.