General Medicines
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Job title:Team Lead – Registry Site Operations

• Reports to: Group Lead - ESR Study & Patient Registry
• Location: Hyderabad
• % of travel expected: Travel required as per business need
• Job type: Permanent and Full time

About the job                                                          

Our Team:

Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.

The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations (SBO) will leverage an untapped combination of talent pool.

Main responsibilities:

Team Lead – Registry Operations will be responsible for end-to-end project planning & execution with support from 10-15 members, this includes stakeholder engagement, resource planning, and monitoring ongoing work.

• People: (1) Mentor the registry study/project management team on day to day as well as exceptional cases/ situations in Registry Study project and site management, Study Start-up Activities, Safety & Quality, Study administration, 2) Monitor progress of work and provide solution to issues and queries for above activities;(3) Resource and back-up planning for business continuity;(4) Identify areas for innovation and implement with external and internal partners;(5) Act as key contact and thought partner for contracting related activities;(6) Effective work allocation to the team;(7) Share best practices and serve as a change agent and facilitator for operational excellence.

• Project: (1) Collaborate with global stakeholders for future projections and setting up the timelines;(2) Ensure that team delivers the ongoing projects as per agreed timelines;(3) Ensure that team follows defined/agreed quality parameters/review before sending out deliverables to the stakeholders;(4)Support team to get resolution on timely basis for technical glitch(es) if any;(5) Closely monitor projects, ensure timely completeness of project tracker, QC of projects, archival of documents in repositories, and maintaining other necessary tracking tools in order to keep trackers and repositories audit readiness.

• Process: (1) Identify and Propose automation solutions to the stakeholders for registry study/project management process;(2) Collaborate with the stakeholders to simplify above process and provide them with real-time updates and final outputs;(3) Encourage team for new and innovative initiatives;(4) Keep abreast of operational excellence techniques and facilitate constant skill up-gradation of organization employees.

• Stakeholder: (1) Support global stakeholders for project planning, resource allocation and ensure the business continuity as per agreed plan(s);(2) Help global stakeholders for process improvements, risk mitigation plans, and new initiatives;(3) Maintain effective working relationship with stakeholders and work with them to provide solutions on ongoing issues/problems;(4) Connect with Registry study management governance leaders, internal stake holders for registry study project, site and data management review for status updates

About you

• Experience: 10+ years of experience with global clinical trial management, quality review, stakeholder management, Project management and project tracking and People management. Project management certification preferred. Strong quantitative, analytical (technical and business) and problem-solving skills is a must. Excellent cross-functional collaboration skill and experience required. Proven self-starter with experience driving efficiency in processes highly desirable.

• Soft skills: Excellent written and oral communication skills. Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.

• Technical skills: Good understanding of the principles of ICH-GCP and applicable local regulatory requirements. Familiarity with CTMS is essential for planning, tracking, and managing registries activities. Proficiency in EDC systems is crucial for collecting, managing, and analysing registries data. Understanding regulations, ICH/GCP guidelines, and other regulatory requirements is vital to ensure compliance throughout the registries. Skills in data management, including data cleaning, validation, and statistical analysis, are important for ensuring the integrity and accuracy of registries data. Ability to identify, assess, and mitigate risks associated with registries to ensure smooth project execution. Take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress. Embrace change and innovation by supporting the evolution of the Registry study function, driving improved effectiveness. Competent with Microsoft Office products.

• Education: Post Graduate degree in Life science/ Pharma/Medicine with >10 years relevant experience

• Languages: High Proficiency in written and spoken English

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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