Study Project Manager I - Oncology

AbbVie•Florham Park, NJ

2d•$109,500 - $208,500

About The Position

The Study Project Manager I drives the connection between science and operational delivery, ensuring operational excellence in planning and executing clinical research studies across all development stages. The role is responsible for ensuring studies are conducted with quality and efficiency, on time, within budget, and in alignment with company objectives. It applies scientific acumen, strategic thinking, innovation, clinical study operations management experience, and stakeholder management to address risks and challenges. The Study Project Manager I leads one or more cross-functional Clinical Study Teams in a matrix environment, guiding clinical operations from planning through execution. For assigned studies, the role oversees development of the clinical study design and associated systems, tools, and documents; study budget creation and oversight; vendor selection, scope development, management, and oversight; and proactive identification and handling or escalation of risks, issues, and efficiency opportunities. The position is an empowered decision maker on operational aspects of study execution and provides leadership to Study Management Associates by leading, delegating, and supporting activities to deliver study milestones.

Requirements

Bachelor’s degree or equivalent degree.
At least 6 years of demonstrated pharma-related and/or clinical research-related experience, or equivalent.

Nice To Haves

Exposure to study initiation through study completion in Phase 1–4 studies.
Medical device trial experience.

Responsibilities

Define and drive operational strategies and deliverables for one or more clinical studies.
Execute clinical studies in compliance with quality standards, including ICH/GCP, global regulations, and AbbVie policies and procedures.
Proactively manage study budgets, timelines, and issues, applying scientific acumen, technical expertise, and a global mindset to achieve study objectives.
Lead the cross-functional Clinical Study Team and clinical operations planning and execution in a matrix environment.
Influence cross-functional stakeholders to achieve study milestones.
Manage vendors and external stakeholders, including site staff, Key Opinion Leaders, and patient groups.
Coach and support cross-functional team members; delegate and empower at the appropriate level; contribute to the Development Operations community.
Contribute to operational efficiencies and bring innovative ideas to teams and studies.
Demonstrate strong communication and problem-solving skills; navigate ambiguity and keep patients and customers at the center of the work.
Develop clinical study designs and associated systems, tools, and documents.
Create and oversee study budgets.
Select vendors, develop scopes, and manage and oversee external vendors.
Identify study risks proactively and address or escalate related issues and efficiency opportunities.
Make operational decisions for study execution.
Create an inclusive and innovative environment in which staff and studies or programs can succeed.
Lead, delegate, and support Study Management Associates' activities to deliver study milestones.