Trial Vendor Senior Manager - FSP

Accountabilities

Accountable for all vendor related operational trial deliverables, according to timelines,

budget, operational procedures, quality/compliance and performance standards.

Collaborates with the VSM for the category specific responsibilities. 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.

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

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

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