Senior Clinical Data Manager

Odyssey Therapeutics, Inc.; Boston (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Odyssey Therapeutics, Inc. seeks a Senior Clinical Data Manager in Boston, MA to oversee clinical data management throughout study phases. This role requires 5+ years of relevant experience in clinical data management, ensuring regulatory compliance and data integrity.

You will collaborate with cross-functional teams, managing external partners while also shaping process improvements. Ideal candidates will exhibit excellent problem-solving skills and attention to detail.

Qualifications

• 5+ years of clinical data management experience in a sponsor and/or CRO setting.
• Comprehensive knowledge of drug development and clinical research processes.
• Strong hands-on experience with data management systems and data analytics platforms.

Responsibilities

• Own clinical data management deliverables from study start-up through close-out.
• Ensure complete, accurate, and regulatory-compliant data.
• Responsible for relationships with data management partners.

Skills

Clinical data management experience

Data management systems (EDC, IRT)

Strong problem-solving skills

Excellent communication skills

Education

BS/MS in a relevant discipline

Job description

Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory and immunology diseases. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting‑edge technologies, and a team of accomplished, world‑class drug hunters. By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.

The opportunity:

Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start‑up through close‑out. Reporting to the Director of Clinical Data Sciences, you’ll independently support active programs and studies, ensuring complete, accurate, and regulatory‑compliant data that powers study reports, publications, and regulatory submissions.

You’ll serve as the primary data management voice on cross‑functional study teams, partnering closely with clinical operations, biostatistics, statistical programming, safety and pharmacovigilance, medical monitoring, regulatory affairs, and external CRO partners to deliver high‑quality, reliable clinical trial data. This is a role for someone who knows established clinical trial paradigms deeply — and is equally energized by new approaches to data aggregation and analysis that advance patient care.

While hands‑on study execution is at the heart of this role, you’ll also have the opportunity to shape how we work: contributing to process development, vendor oversight, and inspection readiness as our clinical data sciences capabilities grow.

Your primary objectives will be:

• Responsible for relationships with data management partners (e.g., CROs and vendors)
• Oversight of outsourced study‑related data management activities including CRF design, data collection, edit checks, and listing reviews, data transfer specifications/agreements with external vendors, data reconciliation (SAEs, labs, other external data), medical coding, UAT, IRT, database lock and archival of data management documents
• Accountable for ensuring data integrity, data quality and timeliness of data management deliverables
• Lead internal cross‑functional data reviews and query management activities
• Monitor key data management metrics and study performance indicators
• Provide feedback on draft protocols and functional area plans and outputs as appropriate (e.g. Clinical Monitoring Plan, Risk Management Plan, Medical Monitoring Plan, Safety Management Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.)
• Maintain data integrity in compliance with GCP, relevant SOPs, regulatory requirements and industry best practices/standards
• Ensure documentation of all data management related activities and Trial Master File readiness
• Attends and represents data management effectively on all assigned studies and programs at relevant meetings
• Support regulatory inspections, audits, and submission activities
• Other related duties as may be determined or assigned

About you:

• BS/MS in a relevant discipline with 5+years of clinical data management experience in a sponsor and/or CRO setting; life sciences background a plus
• Comprehensive knowledge of drug development and clinical research processes, GCP guidelines, regulations, and standards related to clinical data management
• Strong hands‑on experience with data management systems, technologies, and standards, including EDC, IRT, and data analytics platforms
• Strong problem‑solving and critical thinking skills, with keen attention to detail
• Excellent verbal and written communication skills
• Self‑motivated and able to work autonomously, while taking direction and collaborating effectively within a high‑functioning team, with the highest standards of professionalism and ethics

Travel: ~10%

Pay Range Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.