Sanofi Hiring Project Specialist – Trial disclosure

Sanofi Hiring Project Specialist – Trial disclosure

9 July, 2022

Sanofi Hiring Project Specialist – Trial disclosure

For each trial or study managed by the CHC entity, in close collaboration with study and/or project teams i.e., clinical, bio-statistics, regulatory, marketing, patents and legal

  • Conduct and document Clinical trial disclosure assessment per Sanofi policy
  • Plan and prepare high-quality information for posting within required timelines on websites such as CTG (ct.gov), EUCTR, EUDRACT in adherence with guidelines such as Protocol Registration content, updated protocol/trial information, study results, release related redacted documents, lay summaries
  • Ensure consistency of trial/product information across disclosures
  • Prepare and post or hand-off high-quality summaries for relevant websites/portals
  • Track postings on websites, file/archive in relevant systems and maintain audit and inspection readiness
  • Remain abreast of Sanofi Policy or Quality Documents evolution
  • If applicable, provide careful oversight of activities managed in collaboration with Vendors
  • Effective collaboration with stakeholders

Key areas (Weightage)

People (20%)

  • Maintain effective relationship with the study/project team (clinical, bio-statistics, regulatory, marketing, patents and legal, and medical writers as applicable) within the allocated GBU with an end objective to develop high quality information for clinical study disclosure
  • Interact effectively and proactively with all relevant stakeholders (including internal within MedHub)

Performance indicators

  • Feedback from stakeholders (Project/study team and medical writers) on overall satisfaction

Performance (40%)

  • Perform and document applicability assessments based on relevant company transparency policy
  • Diligent planning and preparation of registrations and/or results for varied websites such as CTG (ct.gov), EUCTR, EUDRACT and EU PAS Register according to current guidelines and within required timelines
  • Prepare high quality information and ensure its timely posting on public websites

Performance indicators

  • Adherence to timelines and quality

Process (30%)

  • Prepare and release the Protocol Registration content
  • Prepare and release updated protocol/trial information as appropriate
  • Prepare and release study results Manage/prepare/release related redacted documents
  • Prepare and/or post summaries on Sanofi.com
  • Prepare and/or post Lay Summaries
  • Ensure consistency of trial/product information across disclosures
  • Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness
  • Provide careful oversight of activities managed in collaboration with Vendors
  • In case of deviation, identify root cause, identify and follow up on preventive and corrective actions
  • Remain abreast of Sanofi Policy or Quality Documents evolution

Performance indicators

  • Feedback from stakeholders on quality and timely completion of deliverable Adherence to planning
  • Training compliance and no audit findings
  • Alignment with the Standard process and working guides

Stakeholders (10%)

  • Work in close collaboration with stakeholders involved in trial disclosure activity
  • Proactively liaise with stakeholders and collect information in order to meet timelines

Performance indicators

  • Feedback from stakeholders on satisfaction on deliverables and timely completion of activities

Knowledge, Skills & Competencies/language

  • Working knowledge of preparation of clinical trial disclosure deliverables and posting on applicable portals/websites, as mentioned above (or similar experience which can be leveraged and evolved)
  • Knowledge of ICH and GCP
  • Ability to summarize scientific information and edit text for specific audiences
  • Project management (good sense of organization and prioritization)
  • Excellent interpersonal and communication skills
  • Excellent eye for detail and strong quality mindset
  • Knowledge of global disclosure requirements (US and/or EU) is desired

Qualifications

  • Graduate or post-graduate in Pharmacy/Science
  • 3-4 years experience in clinical development
  • Trial transparency/disclosure experience (desired)
  • Well-versed with computer applications

Apply HERE

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