Instagram
youtube
Facebook

Vendor Start-Up Manager – Irt

5-7 years
$112,000.00 - $186,600.00
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Vendor Start-Up Manager – IRT

Job Location: Durham, North Carolina
Job Type: Full-time
Job ID: R1479183


Job Purpose:

This sponsor-dedicated role reports to the Vendor Category Expert and focuses on ensuring a seamless and accelerated vendor service delivery during the trial start-up phase. The Vendor Start-Up Manager (VSM) provides category-specific technical expertise, proactively mitigates risks, supports the implementation of standardized services, and contributes to overall vendor strategy alignment.


Key Responsibilities:

  • Provide category-specific expertise for trial start-up activities.

  • Collaborate with VPM Vendor Program Manager and study start-up teams to facilitate smooth vendor operations.

  • Develop and execute contingency plans to manage startup-related risks.

  • Coordinate vendor engagement, kick-off, and documentation activities.

  • Ensure protocol changes are communicated and reflected in vendor timelines and budgets.

  • Oversee user acceptance testing (UAT) for IRT systems.

  • Monitor vendor performance and compliance using the FIRST tool.

  • Identify and escalate issues as required; drive corrective actions.

  • Support contract negotiations and budget reviews in collaboration with procurement.

  • Contribute to study specifications and vendor selection process.

  • Facilitate submission document collection from vendors for regulatory requirements.


Additional Clinical Leadership Responsibilities:

  • Lead the clinical team to ensure compliance with ICH-GCP, SOPs, project plans, and contractual requirements.

  • Ensure recruitment targets are met with effective strategies.

  • Oversee clinical quality, monitor standards, and manage clinical risks.

  • Handle project-level financial oversight and identify opportunities for additional services.

  • Conduct stakeholder management and project-related communications.

  • Guide the resourcing, training, and performance feedback for the clinical team.

  • Support clinical aspects of business development, proposals, and bid defense.

  • May serve as a mentor or coach for peers and attend site visits as needed.


Required Qualifications:

  • Education: Bachelor's Degree in a healthcare or scientific discipline (mandatory).

  • Experience: 5–7 years of clinical research or monitoring experience, or equivalent.

  • Regulatory Knowledge: Strong understanding of GCP, ICH, and relevant clinical research regulations.

  • Technical Expertise: Proficiency in project management, clinical trial conduct, vendor oversight, and risk mitigation strategies.

  • Communication: Excellent verbal and written skills in English.

  • Leadership: Proven experience in team leadership, mentoring, and cross-functional collaboration.

  • IT Proficiency: Competent with Microsoft Office applications (Word, Excel, PowerPoint).

  • Soft Skills: Strong organizational, problem-solving, negotiation, and decision-making skills.

  • Cultural Awareness: Ability to work in a global, cross-cultural environment.


Compensation & Benefits:

  • Annual Base Pay Range: $112,000 - $186,600

  • Final offer may vary depending on experience, skills, education, and location.

  • Eligible for additional incentives, bonuses, and a full suite of health and welfare benefits.


Company Overview:

IQVIA is a global leader in clinical research and healthcare intelligence. Through data, technology, and advanced analytics, IQVIA enables the life sciences industry to drive innovation and improve patient outcomes worldwide. Learn more: https://jobs.iqvia.com


Equal Opportunity Employer Statement:

IQVIA is an equal opportunity employer. We value diversity and ensure fair treatment for all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.