Vendor Start-Up Manager – Irt

Vendor Start-Up Manager – Irt

Requirements

• Bachelor’s Degree in health care or other scientific discipline required
• 5-7 years clinical research/monitoring experience or equivalent combination of education, training and experience
• Consolidated knowledge of Project management practices and terminology
• Good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Broad protocol knowledge and therapeutic knowledge
• Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
• Understanding of project finances
• Knowledge of clinical trials – Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct
• Strong written and verbal communication skills including good command of English language
• Problem solving skills
• Planning, time management and prioritization skills
• Attention to detail and accuracy in work
• Results-oriented approach to work delivery and output
• Good influencing and negotiation skills
• Good judgment and decision-making skills
• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
• Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Ability to work across geographies displaying a high awareness and understanding of cultural differences
• Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans)
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
• Conduct regular team meetings and communicate appropriately to achieve objectives
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
• May mentor and coach new peers as they assimilate into this role
• May attend site visits as applicable in support of project delivery
• Reviewing of the vendor and category-related specific sections of the protocol, ensuring vendor expertise is leveraged when refining specifications towards Final Protocol
• Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors
• Quote/proposal review in collaboration with procurement and vendor (if required, support contract negotiations)
• Vendor budget review of final quotes
• Coordinating vendor kick-off meeting and other vendor-specific meetings
• Collecting HA submission documents from vendor, as requested by countries participating in a study
• Performing robust User Acceptance Testing (UAT) for IRT
• Ensuring changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications
• Supporting amendment of vendor contracts with Procurement team
• Optimizing a frontloaded and timely study start-up process in support of a timely vendor DB-go-live
• Proactively creating and maintaining vendor related risk maps with contingency plan for documentation in FIRST
• Documenting issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective actions
• Escalating issues if required to the Vendor Category Expert VCE
• Ensuring vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial

Preferred Qualifications

No preferred qualifications provided.