Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
About the role
- Oncology Late Stage Clinical Scientist overseeing late-stage clinical trials at Pfizer. Ensures data integrity and quality while collaborating with cross-functional teams.
Responsibilities
- Responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- 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) within the assigned program.
- 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; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
- In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
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 5 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval.
- 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
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Clinical Research Project Manager managing clinical trials involving radiation therapy at the Perelman School of Medicine. Ensuring adherence to protocols and supporting operational activities within the team.
Clinical Research Coordinator managing radiation oncology trials at the University of Pennsylvania. Ensuring compliance with study protocols and coordinating patient enrollment and data collection.
Clinical Research Coordinator managing investigator - initiated and sponsored clinical trials in Radiation Oncology. Ensuring compliance with study protocols and supporting patient enrollment and data collection.
UM
Clinical Research Coordinator at Penn's Balderston lab focused on neuroscience of fear and anxiety. Involves human neuroimaging research, collaboration, and study coordination responsibilities.
Clinical Trial Nurse conducting in - home visits for clinical research at IQVIA. Supporting innovative therapies and gaining hands - on research experience with flexible scheduling.
Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
Clinical Research Coordinator overseeing research studies at Florida Cancer Specialists. Responsible for implementation and management of clinical trials under medical supervision.
Senior Clinical Trial Manager at Climb Bio leading end - to - end execution of Phase 1 - 3 clinical studies. Critical role in clinical operations and study management with a focus on quality and compliance.
Senior Clinical Researcher collaborating globally to design and evaluate digital health investigations. Engaging in statistical analysis and contributing to product development for cognitive health.