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