Study Start-Up Data Strategy Lead — Hybrid

BioSpace; South San Francisco (CA); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits

Long-term incentive programs

Job summary

AbbVie is seeking a Clinical Data Strategy and Operations Lead to own data-related study start-up deliverables from protocol development through system go-live. You will drive data strategies, standards, and technologies across cross-functional clinical teams, translating complex concepts into actionable decisions and ensuring compliance with GCP/ICH AbbVie SOPs.

The role requires experience in pharma/clinical research, leadership, and the ability to influence without direct authority.

Qualifications

• Bachelors degree or equivalent; Masters preferred. PMP or Lean Six Sigma Green Belt desired.
• 6+ years pharma/clinical research/data management/healthcare, or 8+ years PM experience.
• Deep understanding of clinical trial processes and clinical technology; lead role preferred.
• Demonstrated functional leadership.
• Ability to influence without direct authority.
• Ability to coach/mentor in a matrix environment.
• Strong communication skills.
• Strong analytical skills.

Responsibilities

• Serve as CDSO study start-up SME; own data-related deliverables from protocol to go-live.
• Lead data management study start-up end-to-end; optimize timelines and quality.
• Ensure consistency of data strategy, CRFs, and surveillance across studies.
• Drive data integrity and translation of data concepts into decisions.
• Adhere to regulatory standards (GCP, ICH, AbbVie SOPs) and evolving guidance.
• Influence outcomes through data and evidence.
• Lead CDSO innovation and cross-functional initiatives.
• Mentor team members.

Skills

Data strategy

CDSO

Project management

Clinical trial data

Leadership

Communication

Analytical skills

Education

Bachelor's degree

Masters preferred

PMP / Lean Six Sigma

Job description

AbbVie is seeking a Clinical Data Strategy and Operations Lead to own data-related study start-up deliverables from protocol development through system go-live. You will drive data strategies, standards, and technologies across cross-functional clinical teams, translating complex concepts into actionable decisions and ensuring compliance with GCP/ICH AbbVie SOPs.

The role requires experience in pharma/clinical research, leadership, and the ability to influence without direct authority.