Project Manager, Study I

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Define and implement operational strategies and deliverables for one or several clinical studies.

• Conduct clinical studies in adherence to quality standards, ICH/GCP, global regulations, and company policies.

• Oversee study budgets, timelines, issues, risks, and opportunities.

• Lead one or more cross-functional Clinical Study Teams.

• Guide clinical operations planning from initiation through execution in a cross-functional matrix setting.

• Manage vendors and external stakeholders, including site personnel, Key Opinion Leaders, and patient groups.

• Mentor, support, delegate to, and empower members of the cross-functional team.

• Contribute to operational efficiencies and propose innovative ideas.

• Develop clinical study designs along with related systems, tools, and documentation.

• Create and supervise study budgets.

• Select, define, manage, and oversee external vendors.

• Make operational decisions regarding the execution of studies.

• Foster an inclusive and innovative atmosphere for staff and studies/programs.

• Provide leadership to Study Management Associates and assist in activities to achieve study milestones.

⛳️ Requirements

• A Bachelor's Degree or an equivalent qualification is mandatory.

• A minimum of 6 years of proven experience in pharma-related and/or clinical research fields or equivalent is required.

• Preferred experience in managing studies from initiation to completion in Phases 1-4.

• Preferred familiarity with Medical Device Trial Experience.

• Experience in managing clinical study operations.

• Knowledge of ICH/GCP, global regulations, and company policies and procedures.

• Experience in vendor and external stakeholder management.

• Exceptional communication and problem-solving abilities.

• Capability to lead cross-functional teams within a matrix environment.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility to participate in long-term incentive programs.