Responsable de Missions Audit clé dans l'audit légal et contractuel chez Exco Socodec. Supervisant les équipes et assurant la qualité des travaux, avec un portefeuille diversifié de clients.
About the role
- Oncology Clinical Development Scientist overseeing clinical trial data integrity and quality. Collaborating with clinical teams and contributing to regulatory submissions and clinical strategy.
Responsibilities
- Responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within Oncology portfolio
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in specific therapeutic and disease area(s)
- Effectively partner with clinical and medical colleagues, clinical operations and other functional lines for successful implementation and execution of clinical trial(s)
- Represent the study team in governance meetings, authors protocols, study level informed consent documents
- Set the clinical data review strategy and lead the team in collection of quality data and review of emerging clinical data and trends
- Analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes in safety profile
Requirements
- PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 3 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 5 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 2 - 3/pivotal space in Oncology
- Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
- Experience working on large data sets
- Proficiency with Microsoft Office and relevant scientific software
- Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
- Experience leveraging a variety of communication tools and techniques to communicate results
- Experience solving problems collaboratively and handling conflict constructively
- Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
- Experience working proactively and independently, organizing tasks, time and priorities of self and others
- Experience building partnerships across the company to achieve the needs of the program
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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