Medical Operations Manager

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

📋 Description

• Provide operational assistance and implementation for research studies and related activities within the North American region (US/Canada)

• Supervise projects in clinical development and post-approval studies, specifically the U.S. Cysview Blue Light Cystoscopy Registry

• Act as the primary operational stewardship and oversight contact for sponsored studies, the U.S. Cysview Registry, and Investigator Initiated Trials (IITs)

• Oversee and enhance study documentation, such as case report forms, data management plans, and monitoring plans

• Manage CROs and external vendors to ensure alignment and delivery in accordance with the scope of work

• Review anonymized electronic data capture data to assess the completeness and quality of the Registry and research projects

• Ensure compliance with clinical trial registry requirements, including updates for ClinicalTrials.gov and Standard Operating Procedures (SOPs)

• Oversee and conduct study audits as required

• Assist Finance with the reconciliation of Registry invoice data and provide input on budgeting and costs

• Support the onboarding of new sites and the initiation of studies

• Collaborate with Legal regarding site contracts and amendments

• Lead study-level risk assessments and identify strategies for mitigation

• Implement clinical studies in line with planned timelines, deliverables, and budgets

• Assist in medical communication and dissemination of data

• Support the operational aspects of publication strategies for abstracts, manuscripts, and scientific congress presentations

• Distribute clinical data to internal stakeholders promptly

• Coordinate publication communications with Global Medical Affairs

• Report directly to the VP of North America Medical & Clinical Affairs

⛳️ Requirements

• Advanced degree (MD, DO, PharmD, PhD) in life sciences or a related field

• 5-7 years of relevant experience

• Experience with Real-World Evidence (RWE) is required

• Previous experience in Urology or Oncology is preferred

• Proven vendor management capabilities

• Experience in clinical study operations, including protocol development and key study documentation

• Familiarity with electronic medical records (EMR)

• Strong project management, leadership of cross-functional teams, and organizational skills

• Excellent verbal and written communication abilities

• Capacity to work independently and complete tasks within deadlines

• Ability to collaborate with and support cross-functional teams

• Strong prioritization skills, attention to detail, and administrative organization

🏝️ Benefits

• Hybrid/fully remote work arrangement with the possibility of occasional travel