Epidemiology Study Operations Manager

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

📋 Description

• Strategically oversee and manage epidemiology-led non-interventional studies with increasing autonomy.

• Assist the Study Leader in vendor selection, scope development, management, and oversight of external vendors/CROs.

• Coordinate and manage study-related deliverables, which includes project plans, timelines, accountabilities, document quality, action completion, and risk escalation.

• Propel study deliverables to adhere to regulatory and process timelines.

• Provide study status updates to cross-functional teams and stakeholders.

• Utilize applicable systems and processes to track and finalize studies and their related deliverables.

• Facilitate the development, review, and approval of study protocols and associated documents.

• Maintain study documentation, including meeting minutes and IRB/EC approvals, in the designated repository.

• Supervise expenditures against the approved budget.

• Recognize, address, and escalate project-related challenges.

• Identify opportunities for efficiency improvements and engage in departmental projects.

• Apply regulatory knowledge to guide the creation of study deliverables.

• Collaborate across functions and organizations to achieve desired business outcomes.

• Take part in audit and inspection preparation and execution.

⛳️ Requirements

• Bachelor’s degree in biological/medical science or relevant healthcare professional field.

• Over 6 years of experience in healthcare, a research institution, or the pharmaceutical sector.

• At least 2 years of experience in project management or operational roles within global companies.

• Preferred background in drug development, non-interventional study lifecycle management, risk management, and/or pharmacovigilance.

• Capability to work collaboratively and build effective relationships with others.

• Adaptability to process and technology changes.

• Familiarity with medical and study terminology and concepts is advantageous.

• Proficient in Windows, Word, and Excel.

• Experienced in using databases, such as clinical trial management systems.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility for long-term incentive programs.