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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for scientific oversight, data integrity and quality of clinical trial(s)
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge
- Effectively partner with clinical and medical colleagues for successful implementation of clinical trial(s)
- Author protocols, study level informed consent documents
- Contribute to authoring of clinical study reports, regulatory responses
- Analyze the emerging safety profile of the drug
- Lead the team in the collection of quality data and review of emerging clinical data and trends
Requirements
What you’ll need- PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 3/pivotal space in Oncology
- Experience leading a team
- Excellent knowledge of clinical procedures, ICH guidelines, GCP
- 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
- 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
- Experience building partnerships across the company
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchdata integrityclinical trial oversightprotocol authoringclinical study reportssafety profile analysislarge data set analysisscientific productivityregulatory responsesclinical procedures
Soft Skills
team leadershipeffective communicationpresentation skillsorganizational skillsproblem-solvingconflict resolutioncollaborative workindependent workpartnership buildingscientific collaboration
Certifications
PhDPharm DMSBABS
