Senior Oncology Clinical Trials Lead

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 159,000 - 286,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning

Paid time off

Savings & investments

Location perks

Job summary

Moderna in Cambridge, MA is seeking a seasoned Clinical Data Lead to support Oncology therapeutic programs and the Clinical Study Lead in the design, execution and evaluation of Phase 1-3 studies. The role focuses on ensuring data quality to support governance and regulatory submissions.

You will collaborate with Clinical Operations, monitor safety data, review study documents and contribute to Investigator Meetings and external partnerships.

Qualifications

• Demonstrated ability to work effectively in a team environment.
• Advanced scientific/clinical oncology knowledge and drug development experience.
• Minimum of 8 years in clinical development within pharma/biotech.

Responsibilities

• Oversee end-to-end delivery of clinical trial protocols.
• Manage study design, initiation, safety data monitoring, data dissemination.
• Coordinate start-up of global studies to ensure site activation and enrollment.
• Review CRFs, data listings, medical coding, and patient profiles for data verification.
• Prepare and review clinical study documents for regulatory standards.

Skills

Data integrity

Medidata Rave

Data analysis

Team collaboration

Communication skills

Education

PhD

PharmD

Masters

Tools

Elluminate

Spotfire

Job description

Moderna in Cambridge, MA is seeking a seasoned Clinical Data Lead to support Oncology therapeutic programs and the Clinical Study Lead in the design, execution and evaluation of Phase 1-3 studies. The role focuses on ensuring data quality to support governance and regulatory submissions.

You will collaborate with Clinical Operations, monitor safety data, review study documents and contribute to Investigator Meetings and external partnerships.