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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This role will be embedded within a client-dedicated FSP team supporting a global pharmaceutical sponsor. The Study Vendor Specialist (SVS) is responsible for study-level oversight and management of third-party vendors supporting clinical trials. Working closely with the Study Management Team (SMT), Functional Quality Representatives, and Procurement, the role ensures vendor performance, compliance, and delivery are aligned with study timelines, quality expectations, and budget parameters. This position plays a key role in driving structured vendor governance, risk identification, and cross-functional collaboration to support successful clinical study execution.

Manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs.

• Responsible for the day-to-day management and oversight of third-party vendors at the study-level.

• Responsible for keeping SMT updated regarding progress, issues tracking

• Ensure study level contracted timelines and deliverables are clear and managed in the context of the vendor. ​​

• Proactively identify, elevate/escalate vendor issues that arise during study conduct to bring to resolution.

• Manage and measure performance of the vendor on assigned study

• Work with vendor to align KPI study delivery, management and measurement of vendor performance, escalating.

• Demonstrate appropriate oversight of vendors through regular, well-structured meetings with vendors (including agendas and minutes)

• Work with Biogen FSP Oversight Manager, Procurement to define project study specs and develop the Vendor Oversight Plan.

• SVS will drive development of specific study level vendor management plans

• Develops required study specific vendor materials

• Support the coordination of vendor performance management meetings to a study level.

• Provide accurate and up-to-date study level vendor information in relevant technology systems

• Driving the cross-functional collaboration and problem solving to ensure study level vendor risk identification and mitigation.

• Work closely with functional quality representatives (FQRs) to ensure vendor’s project deliverables meet quality standards.

• Ensures vendor’s compliance with relevant Biogen policies and procedures.

• Facilitate effective communication and collaboration between SMT and vendor.

• Ensures deliverable transparency from vendor to enable ease of invoice review and responsible for alerting Clinical Trial Lead CTL to invoice anomalies or inconsistencies

Required Skills & Credentials

• 2 + years in clinical operations management, managing clinical studies per quality, timeline, and budget expectations, with a Sponsor company or a CRO.

• Exceptional project-management, risk-assessment, contingency-planning, and communication skills and strong cross functional collaboration.

• Knowledge of clinical study management preferably related to one or more study phases (I, II, III)

• Strong understanding and practical application of Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development

• Demonstrated ability to establish and execute vendor plans according to study needs.

Preferred Skills & Credentials

• Bachelor’s degree or Associate degree

• Clinical Study Management experience working with third party vendors

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.