Externally Sponsored Research Specialist

Main responsibilities:

The SBO ESR project specialist will support the Specialty Care, Vaccines and GenMed GBU with regards to the below activities

Responsible to manage the incoming ESR requests liaising with the medical global and local teams and to ensure ESR are managed as per internal procedures

Responsible for Sponsor/Investigator assessment at study outline review step (sponsor qualification checks).

Act as first recipient of external study proposals submitted in the Sanofi system: evaluate and analyze the request, perform quality checks, identify whether the ESR is a Medical study or an R&D study, identify the Franchise (if any), identify the reviewers and liaise with them to ensure adequate review of the external study proposal by the appropriate review panel.

Responsible for ESR records / document filing (audits, internal control).

Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system. Liaise with appropriate stakeholders.

Provides Fair Market Value (FMV) review and approval to ensure appropriate evaluation criteria are being utilized to provide appropriate benchmarked compensation when ISS /ESC studies are engaged to provide a service to the Sanofi companies

Provides project management support for CDA creation and management ESR studies

Supports protocol QC activity

Provides ESR QC activities and ESR study management in iEnvision

People: (1) Seek alignment with team members and key stakeholders to ensure integration and appropriate prioritization of projects across the portfolio, 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) Conduct routine critical analyses of project objectives and deliverables to proactively identify potential risks and possible efficiencies, and ensuring resources, budgets and project timelines are optimized and realistic;(2) Track relevant project key performance indicators (KPIs) and proactively identify issues and proposals to achieve the project plan;(3) Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate;(4) Contributing to the overall strategy by bringing operational expertise;(5) Ensure operational excellence and compliance readiness

Process: (1) Primary point of contact for FMV and CDA process (2) To review the ESRs budget and to verify that total cost is within the benchmarks practiced within the industry (3) Project management support for CDA creation and management (4) Supports the protocol QC activity (5) ESR QC activities (6) ESR study management in iEnvision

Stakeholder: Work closely with stakeholders from various GBUs, Sanofi Business Operations Activity teams & SBO leadership

About you

• Experience: 3+ years of experience in medical or clinical operations and 2+ years of professional experience managing projects in an international environment, demonstrating effective communication and leadership
• Soft skills: Diplomatic, Intercultural sensitivity, effective leadership on peer-to-peer level
• Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
• Education: Degree in a scientific discipline or related degree with substantial project management and/or project leadership experience
• Languages: Excellent knowledge of English language (spoken and written)
• Pursue Progress, discover Extraordinary

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??. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations?? in Sanofi, globally.

Main responsibilities:

The SBO ESR project specialist will support the Specialty Care, Vaccines and GenMed GBU with regards to the below activities

Responsible to Set up and Managing and Scientific Review Committee (SRC) to review approval meetings for all 4 committee reviews - Company Sponsored Studies & Externally Sponsored Collaborations (CSS & ESC), ISS, Global Health Studies as per the established operating model.

Responsible to manage the incoming ESR requests liaising with the medical global and local teams and to ensure ESR are managed as per internal procedures

Support ESR manager for ESR operational activities

Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system. Liaise with appropriate stakeholders. Provides ESR QC activities and ESR study management in iEnvision for all GBU

Support for ESR records / document filing (audits, internal control).

Provides Fair Market Value (FMV) review and approval

Provides support for CDA creation and management, if needed

People: (1) Seek alignment with team members and key stakeholders to ensure integration and appropriate prioritization of projects across the portfolio, 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) Conduct routine critical analyses of project objectives and deliverables to proactively identify potential risks and possible efficiencies, and ensuring resources, budgets and project timelines are optimized and realistic;(2) Track relevant project key performance indicators (KPIs) and proactively identify issues and proposals to achieve the project plan;(3) Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate;(4) Contributing to the overall strategy by bringing operational expertise;(5) Ensure operational excellence and compliance readiness

Process: (1) Lead governance and stakeholder alignment for SRC meetings, ensuring efficient review of CSS, ESC, ISS, and Global Health Studies. Manage documentation, compliance, and act as the primary liaison for study requestors and global partners. (2) Primary point of contact for FMV and CDA process (3) To review the ESRs budget and to verify that total cost is within the benchmarks practiced within the industry (4) Project management support for CDA creation and management (5) Supports the protocol QC activity (6) ESR QC activities (7) ESR study management in iEnvision

Stakeholder: Work closely with stakeholders from various GBUs, Sanofi Business Operations Activity teams & SBO leadership

About you

Experience: 3+ years of experience in medical or clinical operations and 2+ years of professional experience managing projects in an international environment, demonstrating effective communication and leadership

Soft skills: Diplomatic, Intercultural sensitivity, effective leadership on peer-to-peer level

Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)

Education: Degree in a scientific discipline or related degree with substantial project management and/or project leadership experience

Languages: Excellent knowledge of English language (spoken and written)