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