Study Project Manager I - Oncology

AbbVie; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

AbbVie is recruiting a Study Project Manager I in Irvine to drive the connection between science and operational delivery, ensuring studies are executed on time, within budget, and with quality. You will lead one or more cross-functional Clinical Study Teams and manage planning from design to execution in a matrix environment.

You will bring 6+ years of pharma/clinical research experience, strong stakeholder management, and a growth mindset, partnering with sites, KOLs, and patient groups while

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

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 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 escape 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

Skills

Cross-functional leadership

Budget management

Stakeholder management

Clinical study operations

Communication skills

Education

Bachelor's degree

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

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

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 escape 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 or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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, visit https://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