Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Oncology Late Stage Clinical Scientist responsible for scientific oversight and quality of clinical trials. Collaborating with teams to support development strategies within Late-Stage Oncology portfolio at Pfizer.
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
- Support preparations for Health Authority meetings
- Set the clinical data review strategy and lead 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
- Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings
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 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
Research Coordinator overseeing clinical studies for musculoskeletal injuries in military health. Assisting with project planning and coordination while ensuring compliance with protocols and regulations.
Overseeing and administering clinical research studies and managing study budgets for military health research. Coordinating project planning and ensuring compliance with regulatory requirements.
Senior Biostatistician coordinating clinical trials at Parexel. Leading project teams and ensuring statistical quality in clinical research.
Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
Clinical Research Nurse Coordinator managing clinical research operations at Duke's Trauma, Acute & Critical Care Division. Supervising nursing care and ensuring accuracy in data management.
Clinical Research Coordinator managing clinical trials at Emory University. Overseeing research projects, providing guidance, and ensuring compliance with protocols and regulations.
Senior Clinical Trial Manager managing Phase 1 clinical research studies and collaborating with cross - functional teams in a global biopharmaceutical environment.
HR Manager for Clinical Research Units lead engagement strategies at Fortrea. Partnering closely with site leadership in clinical environments in Dallas, TX or Madison, WI.
Clinical Trial Manager overseeing clinical trials managing operations and compliance in Brazil at IQVIA. Ensuring adherence to protocols and managing country - specific requirements.