Senior Clinical Data Manager - Global Trial Data Lead

100 Eli Lilly and Company

Boston (MA)

On-site

USD 116,000 - 169,000

Full time

4 days ago
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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical, dental, vision benefits
Flexible benefits
Life insurance

Job summary

Centessa Pharmaceuticals, a Centessa subsidiary of Eli Lilly, is seeking a Senior Clinical Data Manager in the US to lead data management activities for global programs. You will work with cross‑functional teams to ensure data quality, timely delivery, and regulatory readiness.

Reporting to the Senior Director of Data Sciences, you will implement data standards, oversee EDC/IRT/ePRO, and support regulatory submissions with robust data documentation and proactive issue resolution.

Qualifications

  • Bachelor’s or Master’s degree in a pharmaceutical/biotech field and 6+ years hands‑on clinical data management experience.
  • Experience with electronic clinical data systems and multiple vendor EDC platforms.
  • Strong collaboration with CROs, vendors, and cross‑functional teams; familiarity with regulatory submissions.

Responsibilities

  • Lead planning and execution of clinical data management activities for global development programs.
  • Develop and oversee data management strategies, including data capture tool design and data processing.
  • Establish and maintain clinical data systems and infrastructure (EDC, IRT, ePRO, ECG).
  • Drive data standards strategy and CDISC/CDASH compliance for regulatory submissions.
  • Coordinate with CROs and vendors to align requirements, timelines and quality.
  • Oversee vendor platforms to ensure regulatory and inspection readiness.
  • Develop data management documentation (plans, transfer plans, data flows).
  • Monitor milestones and communicate risks and status to leadership.
  • Generate data reports for trial oversight and safety reviews.
  • Contribute to clinical/regulatory documents with data management input.
  • Ensure data integrity and GXP/regulatory compliance across data domains.
  • Help develop SOPs and scalable data management processes.

Skills

Electronic data systems
CRO/vendor management
Regulatory submissions knowledge
Clinical data management
CDISC/CDASH standards
Data quality assurance
Communication skills

Education

Bachelor’s or Master’s degree in life sciences/biotechnology

Tools

EDC platforms
Clinical trial technologies
Data management systems

Job description

Centessa Pharmaceuticals, a Centessa subsidiary of Eli Lilly, is seeking a Senior Clinical Data Manager in the US to lead data management activities for global programs. You will work with cross‑functional teams to ensure data quality, timely delivery, and regulatory readiness.

Reporting to the Senior Director of Data Sciences, you will implement data standards, oversee EDC/IRT/ePRO, and support regulatory submissions with robust data documentation and proactive issue resolution.

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