Clinical Program Manager

BRIS 2.025

The Clinical Program Manager (CPM) is responsible for leading a cross-functional study team (including data management, project management, biostatistics, medical monitors, etc.) in the development and execution of UNITY clinical studies. The CPM will be accountable for the delivery of clinical trials within timelines, scope and budget while maintaining quality.

Specific responsibilities include, but are not limited to:

• Coordinating and developing clinical study timelines with Project Management to meet critical milestones and execute within budget
• Managing all operational aspects of study implementation from start-up through database lock while ensuring compliance with GCP, SOPs and other regulatory requirements
• Participating in clinical protocol development and development of associated documentation such as Informed Consent Forms (ICFs), eCRFs, and technical study manuals such as Laboratory or Imaging Manuals, Study Plans (Data Management, Safety, Clinical Monitoring, etc.)
• Management/Oversight of regulatory and core clinical documentation (Trial Master File)
• Oversight of Quality Management as it pertains to a given study or program
• Management of clinical strategic outsourcing: Vendor selection and qualification (managing Request For Proposal and Bid Defense process), Vendor oversight and development of the Vendor management plan and defining/reviewing Quality Metrics
• Management of Central Laboratories

REQUIREMENTS:

• Bachelor’s degree (BS/BA/BScN or higher) in a scientific field
• 6+ years of clinical study management experience and at least three years of clinical study lead or project management experience including study management of clinical trials Phase 1-3
• Experience in managing clinical studies in ophthalmology preferred
• Experience managing outsourced studies.
• Direct site monitoring and expereince of managing audits or undertaking inspection preparedness preferred
• Experienced in the use of EDC systems and an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences (ability to train others on systems use). Highly competent in an electronic environment and the handling of documentation in such environments (prior experience with eTMF systems highly advantageous)
• Ability to work with a high degree of initiative and independence while exercising appropriate judgement when direction is required
• Thorough knowledge of  ICH/GCP guidelines

 Professional and Personal Qualities:

• Strong team player: enjoys working with others, ability to adapt to differences in working styles
• Patient and thorough: understands the importance of managing the detail
• Flexibility: ability to change course with varying high level priorities within the group
• Collaborative self-starter who enjoys the challenge and breadth of activity offered in a small company environment
• Willing to embrace change and work in a changing environment
• Ability to work autonomously to execute to an agreed plan, maturity to flag risks or asses when deviation from the agreed plan is required
• High degree of professional integrity and strong work ethic; takes pride in work product