CE
Care New EnglandClinical Research Assistant III
Clinical Research Assistant III supporting pediatric research projects at Women & Infants Hospital. Collecting research data and overseeing study activities under the PI and/or project coordinator.
About the role
- 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 disciplines to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as needed 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
- May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials
- Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials)
- Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents
- Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas
- Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization
- Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations
- Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification
- Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results
- Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues
- Perform other duties as assigned related to clinical programs
- Support functional area priorities and contribute to or lead departmental initiatives as requested
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, 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 platforms
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
DC
Duke CareersClinical Research Nurse Coordinator
Clinical Research Nurse Coordinator overseeing complex oncology clinical trials within Duke Cancer Institute. Managing study operations, collaborating with multidisciplinary teams, and maintaining regulatory compliance.
EC
Eli Lilly and CompanyClinical Research Scientist – Breast Cancer Franchise
Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross - functional partners in clinical trial design and execution.
SC
School of Information Technology at the University of CincinnatiClinical Research Professional II, Radiology
Clinical Research Professional II coordinating research activities at UC College of Medicine. Engaging in patient recruitment and maintaining compliance with research protocols.
Clinical Trial Manager overseeing planning, execution, and completion of clinical trials for ICON PLC. Collaborating with teams and managing site relationships to ensure compliance and successful delivery.
Senior Manager overseeing clinical trials in Late - stage Oncology at Pfizer. Providing scientific oversight and collaborating with clinical operations for successful trial execution.
Senior Manager in Late Stage Oncology ensuring quality and integrity of clinical trial processes at Pfizer. Collaborating with cross - functional teams to support drug development and regulatory submissions.
Principal Scientist at Merck managing clinical research activities in Immunology with focus on late - stage development. Overseeing clinical trials and collaborating with cross - functional teams.
SH
Syneos HealthSenior Clinical Trial Manager – Poland, hybrid model
Sr Clinical Trial Manager managing clinical trial oversight and ensuring compliance in Poland. Collaborating across teams to meet project milestones and patient safety standards with a hybrid work model.
GE
Senior Clinical Trial Manager at Genmab managing clinical trials and ensuring compliance with regulatory standards. Developing operational plans and coordinating with stakeholders for successful trial execution.