Team Lead - Registry Projects

Job title: Team Lead - Registry Projects

• Hiring Manager: 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 will leverage an untapped combination of talent pool.

Main responsibilities:

The Registry Project Leader (RPL) is responsible for the regional oversight on start-up and follow up activities as well as project oversight of the CPL and CRA within the region for the Rare Disease Registries in close collaboration with the Global Operations Lead - Rare Disease Registries and Medical Affairs staff in the countries. The RPL has responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures, and local regulatory guidelines.

This position will ensure timely support for the below activities in consultation with the Global Operations Lead - Rare Disease Registries and Medical Affairs staff.

Project Management: Responsible for oversight of all the Registries in the assigned region.

• Maintain oversight of the Registries progress and provide global/regional/country status to Global Operations Lead as needed.
• Coordinate the Clinical Project Leads in the region.
• Review and approve site visit reports (Site Selection, Site Initiation, Routine Monitoring and Close Out Visits), follow-up letters (as needed) as back-up for the CPL s if/when needed.
• Maintains oversight and is escalation point for contract related issues and ensures payments are executed by CPL/CRA in accordance with agreed upon payment milestones for each individual site, following the status with the Finance team.
• Coordinate and oversee international data collection projects for the global/region.
• Liaise with Medical Affairs Teams in the countries for any applicable topic.
• Part of, and contribute to the Global Site Operations Team:
  • Attend relevant meetings.
• Take part in activities concerning (but not limited to):
  • process improvement/optimalisation, global management of operational activities of the Registries,
  • creation of materials for regional/global and local execution of the Registries
• Ensure alignment of activities with the Leads of other Regions within the scope of the Global Registries Program.

Study Start-up Activities:

• Oversight of start-up activities, support of CPL and CRA in this process as needed.
• Ensure a financial contract is executed for each site.

Safety & Quality:

• Oversee adequate safety reporting process according to country regulations and SOPs.
• Quality control of study conduction at regional level - with "audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary.

Responsible for training or arrange training for new CPLs/CRAs (if applicable)

Responsible for Training (train the trainer) additional resources hired on a temporary basis in the countries. (if applicable)

To maintain tables, trackers, and databases to follow the study progress regionally and globally.

To know and use all the tools needed.

Support the improvement of internal processes by providing feedback on e.g., CAPA, and (re)writing Quality Management System (QMS) and/or project specific documents.

To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in filing regional documents as required.

Study Meetings: To participate with the rest of the study team in local and international investigators meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

Liaise with Vendor for different activities (startup, onsite monitoring).

• People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business

• Performance: (1) Strategic Planning: Developing comprehensive plans for the initiation, execution, and completion of registries, ensuring alignment with project goals and timelines (2) Protocol Development: Contributing to the creation and refinement of study protocols, (3) Team Leadership: Leading and coordinating cross-functional project teams, ensuring effective collaboration and communication among team members (4) Regulatory Compliance: Ensuring that registries comply with national and international regulatory requirements, including regulations and ICH/GCP guidelines. (5) Resource Management: Allocating resources efficiently, including managing budgets and ensuring the availability of necessary resources for the project (6) Problem-Solving: Addressing and resolving issues that arise during the trial, using strong problem-solving and decision-making skills. (7) Stakeholder Communication: Maintaining clear and effective communication with all stakeholders, including sponsors, vendors, regulatory authorities, and the Registries team (8) Monitoring and Evaluation: Regularly monitoring the progress of the Registries and evaluating the performance of the registries, making necessary adjustments to ensure project success.

• Process: (1) Oversight of all the Registries in the assigned region; (2) Ensure feasibility activities and site selection process; (3) Oversight of start-up activities (4) Oversee adequate safety reporting process (5) Quality control of study conduction at regional/global level (6) Responsible for training or arrange training for new CPLs/CRAs; (7) Support the improvement of internal processes (8) ensure TMF compliance by contributing to the eTMF process; (8) Coordinate and oversee international data collection projects for the region/global (9) Liaise with Medical Affairs Teams in the countries for any applicable topic.(10) Review and approve site visit reports (Site Selection, Site Initiation, Routine Monitoring and Close Out Visits), follow-up letters (as needed) as back-up for the CPL s if/when needed;(11) Maintains oversight and is escalation point for contract related issues and ensures payments are executed by CPL/CRA in accordance with agreed upon payment milestones for each individual site, following the status with the Finance team.

• Stakeholder: (1) Commit to Customers - Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Operations function. (2) Effective communication to stakeholder which involves determining the best methods and frequency of communication for each stakeholder group regarding regular updates. (3) Actively involve stakeholders in the project planning and decision-making processes. Continuously monitor stakeholder engagement and satisfaction. Address any concerns or issues promptly to maintain positive relationships. This also involves being adaptable to changing stakeholder needs and project dynamics. (4) Collect feedback from stakeholders regularly and use it to improve project processes and outcomes.

• Experience:
  • 6+ years of experience in Clinical research & development including 4+ years clinical trial project management experiences.
  • 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.
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
  • Management, leadership, negotiation skills and analytical, and planning abilities.
  • Results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues, reactivity to emergent needs, able to prioritize, time management.
  • Experience in working in global projects and international matrix environment.

• Soft skills:
  • Excellent written and oral communication skills.
  • Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.
  • Demonstrated ability and sensitivity in working across countries that may have different business cultures.
  • Motivated self-starter with critical thinking mindset and enthusiastic achiever attitude.

• 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: Degree in a Pharma/scientific discipline or a related Life science degree, with substantial project management or clinical trials and drug development experience.

• Languages: High Proficiency in written and spoken English.

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