Trial Vendor Senior Manager (TVSM)

Trial Vendor Senior Manager (TVSM)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What will you be doing?

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 SSU 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 Start-up 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.

• Manges 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 call categories not covered by VSMs during start-up

• Initiates/co-ordinates vendor kick-off meetings 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 a 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

You are:

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

• 3+ years of working experience and excellent knowledge of the clinical operations processes and vendor management

• Very good knowledge of clinical trial design and mapping to supplier requirements

• Thorough and technical understanding of 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 communication 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply