Study Project Manager I - Oncology

PowerToFly; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Study Project Manager I to bridge science and operational delivery in clinical research programs. You will lead cross-functional Clinical Study Teams from planning through execution, ensuring quality, on-time delivery within budget, and alignment with company objectives.

The role requires a scientific mindset, program management experience, and strong stakeholder engagement across development stages. This is an on-site opportunity supporting diverse therapeutic areas.

Qualifications

• Bachelor’s Degree or equivalent.
• 6 years of pharma-related and/or clinical research experience or equivalent.
• Preferred exposure from Phase 1-4 studies and/or Medical Device trials.

Responsibilities

• Defines and drives operational strategies and deliverables for one or more clinical studies.
• Ensures studies are conducted in compliance with ICH/GCP and AbbVie policies.
• Manages budget, timelines and study issues with a global mindset.
• Leads cross-functional Clinical Study Teams through planning and execution.

Skills

Cross-functional leadership

Budget management

Stakeholder management

Regulatory compliance

Study management

Education

Bachelor’s Degree or equivalent

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Study Project Manager I drives the connection between science and operational delivery and ensures operational excellence in planning and execution of clinical research studies across all development stages. The Study Project Manager I is responsible for and ensures clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager I achieves these objectives by bringing scientific acumen, strategic thinking, innovation, experience in clinical study operations management and stakeholder management to address risks and challenges. The Study Project Manager I serves as leader of one or more cross functional Clinical Study Teams, leading clinical operations from planning through to execution in a cross functional matrix environment.

Responsibilities

• -Defines and drives the operational strategies and deliverables for one or more clinical studies
  -Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
  -Proactively manages budget, timelines and study issues; brings scientific acumen, technical expertise and global mindset to drive achievement of study objectives
  -Leader of the cross functional Clinical Study Team
• -Leads clinical operations planning through to execution via cross functional matrix environment and influences cross functional stakeholders to drive milestone achievement
  -Effectively manages vendors and a diverse set of external stakeholders including site staff, Key Opinion Leaders and patient groups
  -Brings a growth mindset, demonstrated by a willingness to continuously learn, grow and adapt, give and receive feedback, see challenges as opportunities
• -Coaches and effectively supports cross functional team members, delegates and empowers to the right level, actively contributes to Development Operations community
  -Contributes towards operational efficiencies and brings innovative ideas to their teams and studies
  -Demonstrates excellent communication and problem solving skills
  -Puts patients and customers at the center of what we do
  -Navigates ambiguity and thrives even when not having all the information
• On a given study responsible for (but not limited to) :
  - the development of the clinical study design and associated systems, tools and documents
  - study budget creation and oversight
  - vendor selection, scope development, management and oversight of external vendors
  - Proactively identifying risks and address and/or elevate study related issues and opportunities for efficiency
  - Empowered decision maker on operational aspects of study execution.
• - creating an inclusive and innovative environment where staff and studies/programs will succeed
• Provide leadership to Study Management Associates – lead, delegate and support activities to deliver on study milestones

Qualifications

• Bachelor’s Degree or equivalent degree is required,
• 6 years of demonstrated pharma-related and/or clinical research related experience or equivalent required.
• Preferred exposure in study initiation through study completion in Phase 1-4 and/or Medical Device Trial Experience

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 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.

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

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.