Associate Project manager - ESR

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Job title:AssociateProject Manager -ESR (Externally Sponsored Research)

• Hiring Manager: Project Lead – ESR and Grants, Sanofi Global Hub
• Location: Hyderabad
• % of travel expected: Travel required as per business need
• Job type: Permanent and Full time

About the job

Our Team:

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

Main responsibilities:

The Sanofi Global Hub ESR associate project manager will support the Sanofi GenMed/Vaccines /other Applicable GBUs (Project & Study Management) within Global Medical Operations & Effectiveness, with regards to Externally Sponsored Research (ESR), i.e. Investigator Sponsored Studies and Externally Sponsored Collaborations).

• Global Hub associate Project manager 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.
• Global Hub associate Project manager provides project management support for CDA creation and management to the relevant GBUs for ESR studies or applicable CDA requirement
• Global Hub associate Project manager provides protocol QC activity to the relevant GBUs for ESR/other studies
• Global Hub associate Project manager provides ESR  QC activities and ESR study management into the relevant applicable tools
• Responsible to manage the incoming request up to decision from Sanofi Pasteur and communication to the Requestor as per internal procedures
• Monitor the quality and compliance of data for approved ESR liaising with medical teams and update the relevant tools

• 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, CDA process and ESR requests (2) To review the ESRs budget and to verify that total cost is within the benchmarks practiced within the industry by using the relevant tool, track all such FMV requests until closure, generate FMV reports as per agreed frequency (3) Project management support for CDA creation and management, tracking of CDA request and generate reports as per requirement (4) Protocol QC of ESR studies into the relevant tool and update the tool as per the requirement, document the QC activities (5) 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;(5a) Responsible for ESR information quality in the Sanofi systems (ESR Sanofi system and planning tool);(5b) Act as first recipient of Vaccines external study proposals submitted in the Sanofi system: evaluate and analyse 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;(5c) Liaise with Medical Program Leaders to ensure smooth review of the ESR in 3 steps;(5d) Liaise with appropriate Global Medical Franchise representative and country medical representative;(1e) Responsible for Sponsor/Investigator assessment at study outline review step (sponsor qualification checks);(5f) Liaise directly with the Sponsor-Investigator / ESR Requestor to ensure a smooth communication process during the review steps, including support to use of ISS tool and understanding of the process steps;(6) Coordinate quality of data/information & process for ongoing ESR;(6a) Once ESR is approved, liaise with Medical Study Leaders (or R&D contact) in charge of the operational follow-up of the ESR;(6b) Ensure an accurate and updated database for ESR in the Sanofi system;(6c) Ensure consistency between the Sanofi ESR system and the other Pasteur tools (Project Management tool, Safety Reporting tool);(6d) Responsible for ESR records / document filing (audits, internal control);(6e) Perform Quality Control of assigned ESR and ensure accuracy of data within Sanofi system. Liaise with appropriate stakeholders;(6f) Ensure regular reporting to Sanofi Pasteur Medical Study Governance Leader at a defined timeframe;(6g) Identify issues (process & tools), escalate them to Sanofi Pasteur Medical Study Governance Leader, put in place and follow-up on corrective measures as needed;(6h) Responsible for direct study management

• Stakeholder: Work closely with stakeholders from various GBUs, Sanofi Global Hub Activity teams & Sanofi Global Hub leadership

About you

• Experience: 6 + years of experience in medical or clinical operations and 3+ years of professional experience managing projects in an international environment, demonstrating effective communication and leadership
• Soft skills: Stakeholder & Project management; communication skills; and ability to work independently and within a team environment. Project Management tools experience with project Planning and analytical skills
• Technical skills: Highly proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
• Education: Bachelor/ Master’s degree required – Medical/life sciences/ B Pharm/M Pharm
• Languages: Excellent knowledge of English language (spoken and written)

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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