Vendor Start-up Manager, eCOA, Central Labs or PR&R

Job Description

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as Vendor Startup Manager! #GCO

Reporting to the Vendor Category Expert, the Vendor Startup Manager (VSM) is responsible for providing technical expertise for electronic Clinical Outcomes Assessments (eCOA), Central Labs OR Patient Recruitment & Engagement activities (PR&R) during study startup to the Vendor Program Manager (VPM) and indirectly, to the study start-up team

The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization. This role proactively assesses risk and concludes contingency plans to de-risk study startup.

Your key responsibilities, but not limited to:
• Review of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol
• Contribute to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors
• Quote/Propose review in collaboration with procurement (and vendor). If required, support contract negotiations
• Co-ordinate vendor kick-off meetings and other vendor specific meetings
• Collect Health Authority (HA) submission documents from vendor, as requested by countries participating in a study
• Perform robust User Acceptance Testing (UAT) for electronic Clinical Outcome Assessment (eCOA) and Incident Response Team (IRT)
• Ensure changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications
• Support amendment of vendor contracts with Procurement team
• Optimize a frontloaded and timely study start-up process in support of a timely vendor DB-go-live
• Pro-actively create and maintain vendor related risk maps with contingency plans for documentation in Facilitated Issue and Risk Surveillance Tool (FIRST)
• Document issues identified with vendor oversight / performance in FIRST tool and implement and monitor corrective actions - Escalate issue if required to the Vendor Category Expert (VCE)

Desirable requirements:
• Significant experience in reviewing and designing eCOA technical configuration based on visit schedule and protocol needs while managing licensing and translations of eCOA instruments across multiple therapeutic areas
OR
• Significant experience in reviewing and designing central lab technical configuration based on visit schedule and protocol needs. Collaborating with central lab vendors for multiple activities in database design planning and supporting risks and issues during start up across multiple therapeutic areas
OR
• Significant experience in setting up multiple services related to enrollment and retention of participants in clinical trials. That includes a variety of services such us health Records retrieval, digital recruitment campaigns, call center management, transportation and reimbursement, site and patient engagement & training instruments across multiple therapeutic areas and countries worldwide
• 3+ years expertise and excellent knowledge of the clinical operation processes and vendor management
• Excellent knowledge of GxP and ICH regulations
• Expert knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
• Demonstrated partnering across divisions with internal and external stakeholders
• Demonstrated root cause analysis, problem solving, and solution generation skills
• Experience in User Acceptance testing (electronic Clinical Outcome Assessment & Incident Response Team)
• Knowledge of key deliverables that impact green light milestones and vendor readiness
• Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (Request For Proposal, Request For Quotation, contracting)
• Specific category expertise - specifically such as Central Labs, electronic Clinical Outcome Assessment /electronic Patient Reported Outcome, incident response team, Cardiac and Respiratory diagnostics, PR&R, Imaging reading.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

• Very strong vendor management skills
• Demonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes
• Partnering skills with internal and external stakeholders
• Strong problem solving, negotiation, deadline driven and conflict resolution skills
• Strong influencing skills and timeline driven
• Closely interact with VPM and study startup team during startup

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could achieve here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #GCO