Study Project Manager I P06

AbbVie•Irvine, CA

8d•$109,500 - $208,500

About The Position

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. This role is responsible for ensuring studies are executed 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, managing clinical operations from planning through execution. For assigned studies, the role oversees study design and associated systems, tools, and documents; budget creation and oversight; vendor selection and management; and identification and escalation of risks and issues. The position also provides leadership and support to Study Management Associates and helps create an inclusive, innovative environment for successful studies and programs.

Requirements

Bachelor’s degree or equivalent degree.
Six years of demonstrated pharma-related and/or clinical research-related experience, or equivalent.
Demonstrated communication and problem-solving skills.

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 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 cross-functional Clinical Study Teams and guide clinical operations planning through execution in a matrix environment.
Influence cross-functional stakeholders to drive milestone achievement.
Manage vendors and external stakeholders, including site staff, Key Opinion Leaders, and patient groups.
Coach and support cross-functional team members; delegate and empower appropriately; and contribute to the Development Operations community.
Contribute to operational efficiencies and bring innovative ideas to teams and studies.
Communicate effectively and solve problems.
Keep patients and customers at the center of the work, and navigate ambiguity when information is incomplete.
Develop clinical study designs and associated systems, tools, and documents.
Create and oversee study budgets.
Select vendors, develop scopes of work, and manage and oversee external vendors.
Identify study risks proactively and address or escalate study-related issues and opportunities for efficiency.
Make operational decisions concerning study execution.
Create an inclusive and innovative environment where staff and studies or programs can succeed.
Lead, delegate, and support Study Management Associates' activities to deliver study milestones.