Medical Operations Manager - NA

Photocure•Princeton, NJ

1d•Remote

About The Position

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 oversite of projects in clinical development as well as post-approval studies at Photocure, in particular, 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 will involve both internal and external stakeholder interactions. Relevant stakeholders include 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.

Requirements

Ability to drive process improvement initiatives in concert with our 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.
Must be proactive, self-disciplined, can prioritize. Must be detailed oriented and administratively organized.
Experience in clinical study operations including experience developing protocols and key study documents.
Has experience and can understand electronic medical records (EMR).
Effective project management skills, cross-functional team leadership and organizational skills.
Excellent oral and written communication skills.
Advanced degree (MD, DO, PharmD, PhD) in life sciences or related field
5-7 years of relevant experience.
Experience with RWE required.
Previous Urology or Oncology experience ideal.

Responsibilities

Act as the primary point of contact for operational stewardship and oversight of the research projects including sponsored studies, the U.S. Cysview Registry and IITs (Investigator Initiated Trials).
Oversee and provide input to the development and/or improvement of study specific documentation including case report forms (CRF), data management plan, and monitoring plan.
Manage external contacts, ensuring the CROs and Third-Party Vendors (EDC, CRO, etc.) are in alignment and are delivering per the scope of work.
Review of anonymized data in the electronic data capture system to monitor data entered into the Registry, research projects and ensure completeness and quality.
Confirm compliance with the clinical trial registry requirements (updates to Clinicaltrial.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.
Operational support while onboarding new sites/study initiation.
Interact with external and internal Legal entities to discuss site contracts/amendments.
Leads risk assessment and identifies risk mitigation strategies at the study level.
Execution of 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 dissemination of clinical data internal stakeholders timely
Align with Photocure Global Medical Affairs on topics (e.g. publication communications)