Medical Operations Manager - NA

About the role

The Medical Operations Manager is a cross-functional role responsible for operational support and implementation of research studies and other relevant associated activities at Photocure in the North American region (US/Canada). This hybrid role includes operational oversight of projects in clinical development as well as post-approval studies, particularly the U.S. Cysview Blue Light Cystoscopy Registry, a large multi-center study collecting Real-World Evidence (RWE) from bladder cancer patients undergoing treatment. The position involves both internal and external stakeholder interactions, including third-party vendors such as CROs, study site IRB and contract professionals, as well as interface with Finance and Legal personnel. This position reports directly to the VP of North America Medical & Clinical Affairs.

Responsibilities

• Act as the primary point of contact for operational stewardship and oversight of research projects, including sponsored studies, the U.S. Cysview Registry, and IITs (Investigator Initiated Trials).
• Oversee and provide input into the development and/or improvement of study-specific documentation, including case report forms (CRF), data management plan, and monitoring plan.
• Manage external contacts, ensuring CROs and third-party vendors (EDC, CRO, etc.) are aligned and delivering per the scope of work.
• Review anonymized data in the electronic data capture system to monitor data entered into the Registry and research projects, ensuring completeness and quality.
• Confirm compliance with clinical trial registry requirements (updates to ClinicalTrials.gov, SOPs, etc.), including oversight and execution of study audits as needed.
• Oversee and assist Finance in data reconciliations of Registry invoicing.
• Work with Finance to provide input into budget needs and development/management costs.
• Provide operational support during onboarding of new sites and study initiation.
• Interact with external and internal Legal entities to discuss site contracts/amendments.
• Lead risk assessment and identify risk mitigation strategies at the study level.
• Execute the clinical study against planned timelines, deliverables, and budget.
• Assist in medical communication and data dissemination.
• Contribute to operations related to publication strategy, including abstracts, manuscripts, and presentations at scientific congresses (e.g., AUA, EAU).
• Provide timely dissemination of clinical data to internal stakeholders.
• Align with Photocure Global Medical Affairs on topics (e.g., publication communications).

Requirements

• Advanced degree (MD, DO, PharmD, PhD) in life sciences or related field.
• 5-7 years of relevant experience.
• Experience with Real-World Evidence (RWE) required.
• Previous Urology or Oncology experience ideal.
• Fully remote with ability to travel occasionally.

Skills

• Ability to drive process improvement initiatives in concert with clinical collaborators.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.
• Demonstrated vendor management experience.
• Ability to work independently and execute tasks within deadlines.
• Ability to work with and support cross-functional teams.
• Proactive, self-disciplined, and able to prioritize.
• Detail-oriented and administratively organized.
• Experience in clinical study operations, including developing protocols and key study documents.
• Experience with and understanding of electronic medical records (EMR).
• Effective project management skills, cross-functional team leadership, and organizational skills.
• Excellent oral and written communication skills.

Significant Contacts

• Internal: U.S. cross-functional team members, including field-based counterparts and home office-based functions such as Global and NA Medical Affairs, Legal, Regulatory, Biostatistics, Market Access, and Finance.
• External: Investigators, clinical trial sites, CROs, CRAs, vendors, regulatory authorities, and managed care decision-makers.