Parexel
Trial Vendor Senior Manager - FSP
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Accountabilities
Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards.
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Collaborates with the VSM for the category specific responsibilities.
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Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
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Assigned responsibilities can include but are not limited to:
- Close interaction and collaboration with study team lead and study team members during study lifetime.
- Review of vendor related protocol sections during protocol development.
- Collaborate with Vendor Startup Manager 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.
- 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 frontloaded 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 in FIRST.
- Manages system and portal user access for vendor, sponsor and site staff, maintain access logs.
- Uses Unified Vendor Portal (UVP) 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 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.
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Activities & Interfaces
- Member of the CTT; participant of CTT sub teams as needed.
- Manages all vendor-related activities for study life-time.
- 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 (PTC).
- 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.
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Leadership Capabilities
- Strong relationship building and communication skills with experience in working with diverse cross-functional teams and driving organizational excellence.
- Strong organizational awareness; advanced planning and project management skills.
- Strong interpersonal, negotiation and conflict resolution skills.
- Very strong vendor management skills.
- Strong problem solving, negotiation, deadline driven and conflict resolution skills.
- Strong influencing skills and timeline drive.
Key Performance Indicators
- Timely, efficient, and quality execution of assigned trials and trial-related activities within budget, and in compliance with quality standards.
- Vendor service excellence at study level.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Vendor KPI and KQI dashboards.
- Site readiness monitoring.
- Timely completion of UAT for eCOA and IRT.
- Vendor cost control.
Education:
- Bachelor degree or equivalent degree is required, with advanced degree preferred.
Experience:
- 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management.
- Excellent knowledge of GxP and ICH regulations.
- Very good knowledge of clinical trial design and mapping to supplier requirements.
- Thorough and technical understanding of client specifications for supplier provided services.
- User Acceptance testing for eCOA and IRT.
- Site collaboration and site activation.
- Vendor management; outsourcing, contracting, sourcing, of clinical services.
- Results-driven: demonstrated ability of completing projects on time.
- Ability to work in cross-functional teams and a matrixed environment.
- Strong influencing and negotiation skills.
- Good written and oral communications skills.
- Very good problem-solving skills.
- Demonstrated willingness to make decisions and to take responsibility for such.
- Excellent interpersonal skills (team player).
- Proven networking skills and ability to share knowledge and experience amongst colleagues.
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