Clinical Trial Team Member
Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trials to deliver study outcomes within schedule, budget, quality / compliance, and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Strategy Directors informed about risks, issues, and study progress. Oversees vendor compliance at study level.
Key Accountabilities :
- Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality / compliance, and performance standards.
- Collaborate with the VSM for the category specific responsibilities.
- Responsible for all activities for which no VSM is assigned with, and for all the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Operational Management / Deliverables :
Interacts and collaborates closely with study team lead and study team members during study lifetimeReviews vendor related protocol sections during protocol developmentCollaborates with VSM to the development of Study Specification Worksheet (SSW) to facilitate bid processManages interface with vendors in cooperation with vendor partner functionsQuote / proposal review in collaboration with procurement, support contract negotiations, if requiredContributes to the development of vendor contract amendmentsAccountable for vendor cost control, budget review, invoice reconciliation and PO close-outManages vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trialCovers all vendor activities after study start-up and all categories not covered by VSMs during start-upInitiates / co-ordinates vendor kick-off meeting for categories not covered by VSMsAttends vendor kick-off meeting for VSM supported categoriesOptimizing a front loaded and timely study-start-up process, manages vendor related activities for DB go livePerforms user-acceptance testing (UAT) for eCOA and IRTDrives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and riskCreates and maintains vendor-related risk maps with contingency plan for documentationManages system and portal user access for vendors, sponsor and site staff, maintain access logsUses Unified Vendor Portal to manage vendorUses Clinical Insights to manage vendors and to achieve site readiness timelinesPlans and tracks supply delivery to sites and return of equipment from sitesInteracts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)Acts as an escalation point for vendor-related query managementFollow-up with countries and hubs for their vendor-related risks and issuesDocument issues identified with vendor oversight / performance in FIRST tool and implements and monitors corrective actionActivities and Interfaces :
Manage all vendor related activities for study lifetimePartners with Vendor Program Strategy Director organization to implement the defined program level vendor strategies successfully at both a program and trial levelEscalate risk and issues for selected categories to Trial Vendor Associate Directors Community Lead and / or and Vendor Alliance Lead (VAL) as neededInteracts and collaborates for vendor management with partner functions such as ESP QA and ProcurementAchieve excellence in vendor operations and management through process improvement in collaboration with the Community Lead and GCO Process, Training, and ComplianceActive member of a community(ies) as a citizen within the TVM organizationApply and encourage agile mindset, values, and principles; be an ambassador for agile and a catalyst for these new ways of workingCompliance with Parexel Standards :
Complies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills :
Very strong vendor management skills; outsourcing, contracting, and sourcing of clinical trial servicesResults-driven : demonstrated ability of completing projects on timeStrong influencing and negotiation skillsStrong relationship building and good written and oral communication skillsStrong problem solving, negotiation, deadline driven and conflict resolution skillsDemonstrated willingness to make decisions and to take responsibility for suchExcellent interpersonal skills (team player)Strong organizational awareness; advanced planning and project management skillsProven networking skills and ability to share knowledge and experience amongst colleaguesProficient in written and spoken EnglishKnowledge and Experience :
3+ years direct clinical trial vendor management experience in a CRO or pharma organization requiredExcellent knowledge of GxP and ICH regulationsVery good knowledge of clinical trial design and mapping to supplier requirementsExperience working with diverse cross-functional teams and a matrix environment and driving organizational excellenceExperience in User Acceptance testing for e-COA and IRTKnowledge of key deliverables that impact green light milestones and vendor readinessExperience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), and / or Imaging readingEducation :
Bachelor's degree or equivalent degree is required, with advanced degree preferredEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.