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Team Lead – Registry Site Operations

10+ years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.