Job Title: Team Lead – Registry Site Operations
Location: Hyderabad, India
Job Type: Permanent and Full-time
About the Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India, designed to centralize processes and activities that 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 globally.
Main Responsibilities:
Team Leadership & People Management:
Mentor the registry study/project management team on daily tasks and exceptional situations in registry study project and site management, study start-up activities, safety & quality, and study administration.
Monitor work progress and provide solutions to issues and queries.
Plan resources and backups for business continuity.
Identify areas for innovation and implementation with external and internal partners.
Act as a key contact and thought partner for contracting-related activities.
Allocate work effectively within the team.
Share best practices and serve as a change agent and facilitator for operational excellence.
Project Management:
Collaborate with global stakeholders for future projections and timeline setup.
Ensure timely delivery of ongoing projects as per agreed timelines.
Guarantee quality reviews before sending deliverables to stakeholders.
Support the team in resolving technical issues.
Monitor project progress, ensure timely updates to project trackers, QC of projects, document archival, and maintain audit readiness.
Process Optimization:
Identify and propose automation solutions for registry study/project management processes.
Simplify processes in collaboration with stakeholders and provide real-time updates and final outputs.
Encourage team members to initiate innovative solutions.
Keep abreast of operational excellence techniques and facilitate skill development within the organization.
Stakeholder Management:
Support global stakeholders with project planning, resource allocation, and business continuity.
Assist with process improvements, risk mitigation plans, and new initiatives.
Maintain effective working relationships with stakeholders and provide solutions for ongoing issues.
Connect with registry study management governance leaders and internal stakeholders for status updates on registry study projects, site, and data management.
About You:
Experience:
10+ years of experience with global clinical trial management, quality review, stakeholder management, project management, tracking, and people management.
Project management certification preferred.
Strong quantitative, analytical, and problem-solving skills.
Excellent cross-functional collaboration skills.
Proven self-starter with experience driving efficiency in complex processes.
Soft Skills:
Excellent written and oral communication skills.
Strong organizational and project management abilities.
Ability to meet deadlines and manage stakeholders effectively.
Technical Skills:
Good understanding of ICH-GCP principles and applicable local regulatory requirements.
Familiarity with CTMS for planning, tracking, and managing registry activities.
Proficiency in EDC systems for collecting, managing, and analyzing registry data.
Thorough knowledge of regulations, ICH/GCP guidelines, and regulatory requirements for compliance.
Expertise in data management, including cleaning, validation, and statistical analysis.
Risk management skills to identify, assess, and mitigate risks associated with registries.
Proficiency with Microsoft Office products.
Education:
Postgraduate degree in Life Science, Pharma, or Medicine with over 10 years of relevant experience.
Languages:
High proficiency in written and spoken English.
Gujarat :
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