Associate Project Manager-Registry Study Managemnet

Job title: Associate Project Manager - Registry Study Management

• Hiring Manager: Project Lead - ESR and Grants
• Location: Hyderabad/Bogota
• % 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 RD, 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 Associate Project Manager is responsible to support the Registries Team in the operational execution of the Global Rare Disease Registries.

This position will ensure timely support for the below activities in consultation with the Registries team.

Project Planning and Coordination:

• Regularly review the project updates, including timelines, milestones, and resource allocation and raise any flags to the Registries team.
• Coordinate with international/external team/CRO teams to ensure alignment and effective collaboration for project delivery.
• Meeting facilitation, meeting minutes and miscellaneous administrative items might be asked.
• Dashboard development and Metrics follow up.

Stakeholder Management:

• Communicate regularly with internal/external stakeholders, including cross functional team, Investigator, regulatory bodies.
• Ensure that all parties are informed about project progress, changes, and any issues that arise.

Regulatory Compliance:

• Ensure that the project adheres to all relevant regulatory requirements and guidelines.
• Manage documentation and reporting to meet compliance standards.

Risk Management:

• Identify potential risks and support to develop mitigation strategies.
• Monitor and address risks as they arise to minimize impact on the project.
• Keep track of identified risks for closure and documentation.

Quality Assurance:

• Support to implement quality control measures to ensure the accuracy and reliability of operations.
• Support in case of any audit or inspection.
• Manage and support reviews to maintain high standards.

Budget Management:

• Support site payments, site payments reconciliation and forecasting.
• Monitor expenses and make adjustments as necessary to stay within budget.
• Budget related metrics development, preparation, and reporting.
• Tracking of project budget/expenses and maintain all relevant trackers/documents.
• Miscellaneous administrative activities

Reporting and Documentation:

• Maintain detailed records of project activities, decisions, and outcomes.
• Prepare and present regular reports/metrics to stakeholders on project status and performance.
• Support to track project KPIs.

Ad - Hoc Assignments: As per need any ad- hoc assignments to be performed.

• People: (1) Seek alignment with internal/external stakeholders, team members and key stakeholders to ensure integration and appropriate prioritization of registry study activities, and compliance with approved processes/SOPs/Regulations; (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.

• Process: In coordination with Registries team manage the below process

(1) Oversee the assigned registry studies by demonstrating a clear understanding of the registry study strategy and project activities, (2) Ensure an effective communication across internal and external project teams; (3) Support and coordinate the registry data analysis requirements (4) Manage the site payments and track all forecasted budget utilization and appropriate budget metrics reporting including payment/invoice tracking/reconciliation (5) Provide oversight on the execution of all assigned registry studies (6) Coordinate for project audit or inspection; (7) Provide metrics, KPI s and other business analytics to the Registry Team/internal stake holders as per the frequency defined

• Stakeholder: (1) Understand, meet, and excel internal and external stakeholders expectations to create positive impact through the evolution of the registry function. (2) Cooperate Transversally collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry programs efficiency and execution.

About you

• Experience:
  • 5+ years experience in project and management, including 3+ years experience in Clinical research development and/or real-world evidence (RWE) management
  • Strong quantitative, analytical (technical and business) and problem-solving skills is a must.
  • Excellent cross-functional collaboration skill with 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.
  • PM certification (preferred).
  • 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.

• Technical skills:

• Knowledge of Clinical studies, GCP, ICH standards and standard regulatory requirement.
• Ability to think broadly and long-term to drive excellence in execution and timely decision making based on information available to support compliant and efficient delivery of study milestones.
• Demonstrate ability to achieve targets and deadlines through the duration of the study via

Registries team objectives.

• Be technology oriented and comfortable with emerging technologies, mobility applications,

and analytics tools. Experience in Smart sheets as beneficial.

• Education: Degree in a Scientific discipline/Pharma 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

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !