Biomarker Operations Senior Manager — Hybrid In-Office

Moderna Therapeutics; Cambridge (MA); Presencial; USD 131.000 - 209.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive healthcare, plus voluntary

Well‑being resources (fitness, mental)

Family planning benefits

Generous paid time off and sabbatical

Savings and investments

Location‑specific perks and extras

Descripción de la vacante

Moderna Therapeutics is seeking a Biomarker Operations Senior Manager to support clinical teams and collaborate with external biorepositories, assay labs, and CROs. You will ensure biosample plans and management are compliant with GCP/ICH across multiple trials.

Qualifications include a life sciences degree, 5+ years of clinical research experience with sponsors, and hands-on biomarker sample management. The role emphasizes process development and cross-functional collaboration.

Formación

• Bachelor’s degree in a life science-based subject; advanced degree preferred.
• Minimum of 5 years of clinical research experience which must include sponsor experience.
• Direct experience with clinical sample management.
• Prior process development experience is very helpful.
• Familiarity with databases is helpful.
• Solid understanding of GCP/ICH is required.
• Strong communication skills and attention to detail.
• Demonstrated ability to multitask.

Responsabilidades

• Independently support to the clinical teams driving agreed upon biomarker sample management plans for the clinical trials
• Lead the review of biomarker sections of clinical protocols, clinical kit development, study/lab manuals and consent forms
• Promote process improvements for clinical sample lifecycle
• Lead the development of processes and procedures for standardized language, biomarker usage, and data reporting
• Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH
• Oversee clinical assay vendor logistics (routine sample analysis meetings, address sample issues, sample shipments)
• Lead efforts to resolve sample issues at Central Labs and 3rd-party vendors

Conocimientos

Clinical sample management

GCP/ICH knowledge

Communication skills

Multitasking

Educación

Bachelor’s degree in life sciences

Advanced degree preferred

Herramientas

Databases

Descripción del empleo

Moderna Therapeutics is seeking a Biomarker Operations Senior Manager to support clinical teams and collaborate with external biorepositories, assay labs, and CROs. You will ensure biosample plans and management are compliant with GCP/ICH across multiple trials.

Qualifications include a life sciences degree, 5+ years of clinical research experience with sponsors, and hands-on biomarker sample management. The role emphasizes process development and cross-functional collaboration.