Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
About the role
- Lead oncology clinical studies coordinating with development teams and executing clinical plans. Collaborate with various disciplines to ensure comprehensive study representation and success at Pfizer.
Responsibilities
- Lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology.
- Work in close collaboration with the Global Development Lead (GDL) and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s).
- Lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines.
- Work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as need within clinical study teams.
- Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s).
- Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results.
- Support execution for all FIH programs through proof-of concept.
- Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
- Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
- Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.
- Support and assist in the development of publications, abstracts, and presentations.
Requirements
- Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
- Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
- Experience in or strong understanding of Oncology Drug Development especially in Early Development
- Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Strong scientific writing skills and communication skills (written and verbal)
- Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
- Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
- Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance
- Experience building consensus and driving change across all levels of the organization including senior management
- Data listing review experience
- Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate
- Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Pfizer Retirement Savings Contribution
- Paid vacation
- Paid holiday and personal days
- Paid caregiver/parental leave
- Paid medical leave
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
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