Novartis Life Sciences Associate Clinical Sourcing Manager Job, Apply Online

379537BR

Associate Clinical Sourcing Manager

Job Description

Associate Clinical Sourcing Manager (Min B2 certification French / Italian)

Location – Hyderabad #LI Hybrid

About the Role:

The Associate Clinical Sourcing Manager generates, negotiates and executes contracts to support the utilization of clinical Contract Research Organizations (CROs) for Novartis Clinical Trials. Assuring the business of a compliant, high quality, timely and cost-effective external service delivery to support the Novartis drug development pipeline. The Associate Clinical Sourcing Manager also participates in projects and initiatives to ensure Clinical Contracting & Outsourcing Management is prepared to successfully respond to the changing needs and requirements (legal, operational, regulatory, and financial) of our customers.

Key Responsibilities:

• Prepare and release RFI, RFP and RFQs and negotiate with existing and new suppliers to support business for new requests as well as re-negotiating scope changes.
• Act as the main point of contact with vendors for negotiation of the scope of work, study assumptions, pricing, and payment schedules.
• Negotiate, develop, and implement contract frameworks including MSA’s & SLA with key suppliers and ensure full implementation.
• Ensure agreements are commercial advantageous to Novartis while minimizing risk through close collaboration with functional partners such as legal, finance, and QA.
• Drive annual efficiency improvements in applicable spend categories and responsible for complete contract packages for clinical ESP activities. Secure all necessary approvals to ensure compliance to SOX and company procedures.
• Contribute to vendor audit requests and facilitate corrective action plans. Ensure ESPs are delivering in line with expectations and contracts.
  • Planning, prioritizing and managing projects taking into account priorities, resources, budgets, issues and constraints to achieve desired results; defining clear project scope and objectives; applying software and tools to plan, track and report status.
  • Achieving results by proactively building long-term, balanced and effective relationships, understanding the collaborator landscape and demonstrating political astuteness across business structures and networks.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

Essential Requirements:

• Detailed understanding of the clinical development process and robust understanding of the management of clinical trials. Excellent influencing and negotiating skills.
• Solid understanding of contractual legal terms and conditions and excellent understanding of the Clinical CRO marketplace including central laboratories, reference laboratories and specialty providers
• Experience in financial understanding as it relates to clinical trial contracts and cost elements
• Analyzing specifications for optimization. Linking specification to customer value, challenging specification confidently. Conveying messages clearly and convincing stakeholders.
• Analyzing problems, considering and profiling alternatives; willingness to make timely, balanced recommendations and business decisions.

Desirable Requirements:

• University/Advanced degree is required, Lifesciences/Chemistry / Biochemistry or Pharmaceutical sciences is required (Added advantage – Min B2 certification is required in French / Italian language).
• 5+ years of Clinical Development / Pharma R&D / Procurement & Outsourcing within the Pharma or CRO industry is required with language expertise in French / Italian as a mandate ask.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Division: Operations

Business Unit: Procurement

Country: India

Work Location: Hyderabad, AP

Company/Legal Entity: Nov Hltcr Shared Services Ind

Functional Area: Procurement

Job Type: Full Time

Employment Type: Regular

Shift Work: No

Early Talent: No

APPLY ONLINE

Possible Interview Questions for the Technical Round:

1. Can you explain the importance of source data verification in preclinical and clinical documents? How would you approach identifying content inaccuracies in such documents?
   • Answer: Source data verification is crucial in ensuring the validity and accuracy of information presented in preclinical and clinical documents. As an Associate QC Specialist, I would carefully review the documents, comparing the information with the cited sources and post-text sources. By conducting thorough assessments, I would identify any deficiencies or inaccuracies and provide factual evidence to support my findings. This process helps maintain the integrity and reliability of the documents filed with Health Authorities.
2. How would you handle complex clinical and scientific data during the review process of clinical summary documents? How would you effectively communicate any inaccuracies to the document authors?
   • Answer: When reviewing clinical summary documents, it’s essential to have a strong understanding of complex clinical and scientific data. I would carefully analyze the data, ensuring that it is accurately represented and interpreted in the document. If any inaccuracies or deficiencies are found, I would approach the document authors with factual evidence and clear communication. By providing specific examples and explanations, I would effectively convey the inaccuracies and collaborate with the authors to address and rectify them.
3. Describe your experience with cross-divisional support and quality review of division-specific documents. How would you ensure consistency and adherence to quality standards?
   • Answer: In my previous role, I provided cross-divisional support by conducting quality reviews of various division-specific documents, such as CSRs, CERs, and Tabular Listings. To ensure consistency and adherence to quality standards, I would follow established guidelines and templates, paying attention to detail and accuracy. By providing constructive feedback and suggestions, I would work collaboratively with the respective teams to improve the quality of the documents and ensure alignment with regulatory requirements.
4. Can you discuss a time when you worked independently to deliver results within defined timelines? How did you prioritize your tasks and maintain productivity?
   • Answer: In a previous project, I was responsible for reviewing clinical summary documents and providing feedback within a strict timeline of four working days. To prioritize my tasks and maintain productivity, I established a structured workflow and timeline, allowing sufficient time for each document review. I utilized effective time management techniques, such as setting deadlines for specific sections and allocating dedicated time for comprehensive reviews. By maintaining focus, organization, and efficient work habits, I successfully delivered results within the defined timelines.
5. How have you utilized your computer technical skills and ability to learn new systems quickly in a regulatory environment? Can you provide an example of a situation where you applied these skills to enhance document development or efficiency?
   • Answer: In my previous role, I leveraged my computer technical skills to develop and optimize documents using software such as Word, Excel, and PDF tools. I quickly grasped new systems and software platforms, allowing me to enhance document development processes and improve efficiency. For instance, I implemented automated templates in Word to streamline the creation of standardized sections, saving time and ensuring consistency. Additionally, I utilized Excel’s data analysis capabilities to extract meaningful insights from large datasets, contributing to the accuracy and efficiency of document preparation.