Job title: Clinical Project Assistant

• Hiring Manager: Project Lead - ESR and Grants
• 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 tocentralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, andR&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, andCommercial 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 Clinical Project Assistant (CPA) will support for the below:

Provide support to the Registries team for the set up and administration of electronic Trial Master File (eTMF) ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines and company Corporate and Local Standard Operating Procedures (SOPs).

Responsible for TMF archiving process -Preparation of archiving, collection, reconciliation and filing of relevant documents.

Manage the upload of documents for all existing and new sites and ensure a primary Quality control (QC).

Provide administrative support with project management activities.

Coordinate the project schedule and ensure timely updates of key milestones and partner with Registries team.

Develop and maintain relevant sections of various Registry materials.

Support project budgetary tracking and or site payments as needed.

Prepare correspondence, including meeting minutes, for the project team and/or customer.

Manage and coordinate core file reviews and support audits as needed.

Manage project specific e-Training tracking and oversee compliance.

Coordinate and support onboarding of new Key Project Team Members and system access.

Update and maintain Registries SharePoint.

Perform miscellaneous administrative tasks as necessary.

• People: (1) The CPA is part of the study team and will collaborate with the people involved in the conduct of the registries from the start-up, up to the closing and archiving activities.

(2) CPA will interact with the clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site's staff, when applicable, to ensure that all the administrative tasks are completed in a timely manner.

• Performance: (1) Maintain registry study documents (2) conduct routine QC check of registry study documents

• Process:

(1) Responsible for the eTMF set up system for the Registry Registries (2) Set-up, manage and keep the local trial master files (paper & electronic) up to date in association with the CPL and CRAs in accordance with the applicable SOPs for filing of trial documents in such a way that any relevant information can be presented promptly during audits and inspections. (3) Manage the upload of documents for all existing and new sites and ensure a primary Quality control (QC). (4) Ensure correct and proper classification of the documents in the eTMF system (5) Control study team compliance to ensure TMF inspection-readiness at any time (6) To ensure completion and tracking of the volume of documents uploaded in the system (7) Responsible for TMF archiving process -Preparation of archiving, collection, reconciliation and filing of relevant documents.

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

About you

• Experience:
  • 3+ years of experience in Clinical research & development including clinical trial eTMF document management experiences.
  • Understanding of ICH GCP guidelines and clinical trial methodologies required.
• Soft skills:
  • Excellent written and oral communication skills needed.
  • Excellent eTMF management skills.
  • Ability to maintain confidentiality of data and information during interactions with study staff at all levels and across studies and sponsors.
  • Effective relationship management, sites, and study teams.
• Technical skills:
  • Good attention to detail
  • Methodical approach to work and prioritization of tasks
  • Understanding of the principles of ICH-GCP and applicable local regulatory requirements
  • Be comfortable with emerging technologies, mobility applications.
  • Work with Others
  • Excellent cross-functional collaboration skill and experience required.
  • Competent with Microsoft Office products.

• Education: A bachelor's degree in life sciences or a related field.

• 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.

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