Clinical Trial Vendor Senior Manager - FSP

Job Summary:

Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) 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 (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) 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 lifetime 
• Reviews vendor related protocol sections during protocol development 
• Collaborates with VSM to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion 
• Manages interface with vendors in cooperation with vendor partner functions 
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required 
• Contributes to the development of vendor contract amendments 
• Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
• Manages vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial 
• Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up 
• Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs 
• Attends vendor kick-off meeting for VSM supported categories 
• Optimizing a front loaded and timely study-start-up process, manages vendor related activities for DB go live 
• Performs user-acceptance testing (UAT) for eCOA and IRT 
• Drives 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 risk 
• Creates and maintains vendor-related risk maps with contingency plan for documentation  
• Manages system and portal user access for vendors, sponsor and site staff, maintain access logs 
• Uses Unified Vendor Portal to manage vendor 
• Uses Clinical Insights to manage vendors and to achieve site readiness timelines 
• Plans and tracks supply delivery to sites and return of equipment from sites 
• Interacts 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 management 
• Follow-up with countries and hubs for their vendor-related risks and issues 
• Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action 

Activities and Interfaces:

• Manage all vendor related activities for study lifetime 
• Partners with Vendor Program Strategy Director organization to implement the defined program level vendor strategies successfully at both a program and trial level 
• Escalate risk and issues for selected categories to Trial Vendor Associate Directors Community Lead and/or and Vendor Alliance Lead (VAL) as needed 
• Interacts and collaborates for vendor management with partner functions such as ESP QA and Procurement 
• Achieves excellence in vendor operations and management through process improvement in collaboration with the Community Lead and GCO Process, Training, and Compliance  
• Active member of a community(ies) as a citizen within the TVM organization 
• Apply and encourage agile mindset, values, and principles; be an ambassador for agile and a catalyst for these new ways of working

Compliance with Parexel Standards:

• Complies with required training curriculum  
• Completes timesheets accurately as required  
• Submits expense reports as required  
• Updates CV as required  
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements  

Skills:

• Very strong vendor management skills; outsourcing, contracting, and sourcing of clinical trial services 
• Results-driven: demonstrated ability of completing projects on time 
• Strong influencing and negotiation skills 
• Strong relationship building and good written and oral communication skills 
• Strong problem solving, negotiation, deadline driven and conflict resolution skills 
• Demonstrated willingness to make decisions and to take responsibility for such 
• Excellent interpersonal skills (team player) 
• Strong organizational awareness; advanced planning and project management skills 
• Proven networking skills and ability to share knowledge and experience amongst colleagues. 
• Proficient in written and spoken English 

Knowledge and Experience:

• 3+ years direct clinical trial vendor management experience in a CRO or pharma organization required
• Excellent knowledge of GxP and ICH regulations 
• Very good knowledge of clinical trial design and mapping to supplier requirements 
• Experience working with diverse cross-functional teams and a matrix environment and driving organizational excellence 
• Experience in User Acceptance testing for e-COA and IRT 
• Knowledge of key deliverables that impact green light milestones and vendor readiness 
• Experience 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 reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes) 

Education:

• Bachelor's degree or equivalent degree is required, with advanced degree preferred 

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.