Associate HR Partner supporting employee operations at CPS Clinical Research Units. Providing HR guidance and managing employee relations in a clinical environment with on - site presence.
About the role
- Standing at the intersection of science and strategy, responsible for clinical trial oversight in Oncology. Partnering with cross-functional teams for successful execution of trials.
Responsibilities
- Responsible for scientific oversight, data integrity and quality of clinical trial(s)
- Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s)
- Represent the study team in governance meetings and submissions
- Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
- Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends
- Analyze the emerging safety profile of the drug
- Follow relevant SOPs and regulations and seek opportunities to further improve quality and efficiency of clinical procedures
- May be a subject matter expert or business process owner for a relevant SOP or procedure
Requirements
- 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 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
- 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 to include medical, prescription drug, dental and vision coverage
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