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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose

Job Description

The Clinical Data Strategy and Operations(CDSO)Data Strategy Lead serves as the study start-up domain expert and key strategic partner to the clinical study team, owning all data-related study start-up deliverables from protocol development through system design and go-live. The role leads cross-functional collaboration to ensure data strategies, standards, and technologies are consistently embedded into clinical plans, while translating complex data and technology concepts into actionable decisions for the study team. Through strong project management, risk oversight, and continuous process optimization, the Data Strategy Lead is key to ensuring successful clinical trial technologydelivery.

Responsibilities

• Serves as the CDSO study start-up subject matter expert 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, partnering both within CDSO and across the study team to enable on-time studystart. Leverages operational analytics and project management tools tooptimizeexecution, track progress, and escalation and resolve issues affecting timelines or quality.
• Ensures consistency in data strategy, standards, CRFs, and surveillance approaches across studies and therapeuticarea(s). Translates complex data, technology, and standards concepts into clear, decision-ready guidance for study teams.
• Drives the pull-through of critical-to-quality factors and data criticality assessments, ensuring they are translated and implemented into downstream data systems.
• Ensures adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stays abreast of evolving guidance.
• Influences without direct authority, using data and evidence to drive aligned, mutually beneficial outcomes for AbbVie.
• Leads CDSO innovation and process improvement initiatives and participatesin cross-functional initiatives.
• Responsible for coaching and mentoring team members.

This role is a hybrid role with 3 days a week onsite.

Qualifications

• Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred. PMP Certification or Lean Six Sigma Green Belt desired.
• Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred
• Demonstrated performance as a functional leader
• Demonstrated ability to influence others without direct authority
• Demonstrated ability to successfully coach / mentor in a matrix environment
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html