Clinical Data Strategy and Operations Program Lead I - Oncology- HYBRID

Allergan; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

Qualifications

• Pharma or clinical research experience (3+ years) or 5+ years in project management.
• Strong understanding of clinical trial processes and technology.
• Proven leadership capabilities and ability to influence without authority.
• Excellent communication and analytical skills.

Responsibilities

• Lead CDSO study teams and serve as the operational lead for assigned studies.
• Act as single point of contact and coordinate CDSO study activities.
• Engage cross-functional teams to meet program objectives.
• Use operational analytics and PM tools to optimize program execution and track progress.
• Ensure compliance with GCP, ICH, SOPs and local regulations.
• Mentor Data Science Associates and participate in process improvements.

Skills

Leadership

Communication

Analytical

Project management

Education

Bachelor's degree or higher

Job description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).

Responsibilities

• Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents DS as a member of the cross-functional study team.
• For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams.
• Interacts with and influences cross-functional team members to achieve program and study objectives.
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
• Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance.
• Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources.
• Participates in CDSO and cross-functional innovation and process improvement initiatives.
• Contributes to study execution “lessons learned” across functions.

Qualifications

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

• Must have at 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience)

• Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred

• Demonstrated effective leadership skills

• Demonstrated ability to influence others without direct authority

• 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in 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 toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s 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.

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