Hybrid Data Strategy Lead, Clinical Trials

AbbVie Inc.; Cambridge (MA); Hybrid; USD 110,000 - 209,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie Inc. is seeking a CDSO Data Strategy Lead to own data-related start-up deliverables from protocol development to system go-live. The role drives cross-functional collaboration, data standards, and process optimization to ensure timely study start and data quality.

The position requires 6+ years in pharma/clinical data or 8+ years in project management, with a hybrid work model (3 days onsite) in Cambridge, MA. Strong leadership and communication skills are essential.

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent.
• Master's degree preferred.
• PMP Certification or Lean Six Sigma Green Belt desired.

Responsibilities

• Serves as the CDSO study start-up SME and single point of contact for assigned studies, owning all data-related start-up deliverables from protocol development through system go-live.
• Leads data management study start-up end-to-end, collaborating with CDSO and study teams to enable on-time study start.
• Ensures consistency in data strategy, CRFs, and surveillance approaches across studies and therapeutic areas.
• Translates complex data, technology, and standards concepts into clear, decision-ready guidance for study teams.
• Drives critical-to-quality factors and data criticality assessments into downstream data systems.
• Ensures adherence to GCPs, ICH Guidelines, AbbVie SOPs, and regulatory requirements; stays current on guidance.
• Influences without direct authority using data to drive mutually beneficial outcomes for AbbVie.
• Leads CDSO innovation and process improvement and participates in cross-functional initiatives.
• Coaches and mentors team members.

Skills

Leadership

Influence without authority

Coaching / mentoring

Communication skills

Analytical skills

Education

Bachelor's degree (business / MIS / CS / life sciences)

Master's degree preferred

PMP / Lean Six Sigma Green Belt desired

Job description

AbbVie Inc. is seeking a CDSO Data Strategy Lead to own data-related start-up deliverables from protocol development to system go-live. The role drives cross-functional collaboration, data standards, and process optimization to ensure timely study start and data quality.

The position requires 6+ years in pharma/clinical data or 8+ years in project management, with a hybrid work model (3 days onsite) in Cambridge, MA. Strong leadership and communication skills are essential.