Clinical Study Manager

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.

Responsible for the global execution of large, complex clinical trials from study design through study close out, working closely with CRO's and trial sites. Identify process improvement initiatives that support our rapidly growing organization.

Duties and Responsibilities include:

• Provide leadership and direction to clinical site management team members from study start through to closure
• Ensure proper conduct of clinical trials in accordance with the appropriate study plans e.g. monitoring plan along with applicable prevailing regulations , Good Clinical Practices, and pertinent standards to achieve project goals, timelines and quality
• Contributes to the drafting and review of study level documents.
• Provides proper oversight of CROs and other third-party vendors to help ensure high quality of delivery according to the agreed scope, budget and timelines
• Provide operational input into protocol development
• Contribute to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, vendor oversight plan, project specific training plan, data review plan, etc.
• Set-up and maintenance of study systems e.g. Clinical Trial Management System (CTMS), Trial Master File (TMF).
• Ensuring compliance with appropriate clinical trial registry requirements
• Identify operational study risks and implement risk mitigation strategies
  
  

This role might be for you if:

• You naturally work in a transparent, respectful, accountable and collaborative way.
• You take a proactive and self-disciplined approach to leading projects with a strong ability to meet deadlines and prioritize accordingly
• You have a track record of effectively managing vendors
  
  

Requirements

Description

Education/Training

Bachelor's degree required

Experience

5+ years of experience leading international clinical trials, including experience developing key study documents, is required

Skills/Abilities

Trial management software and MS Office Suite experience required

Other

Excellent verbal and written communication skills required

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.