Clinical Project Manager

General Functions and Scope

We are looking for a hands-on Clinical Project Manager to work with project teams to prepare, implement and manage clinical development plans and provide clinical research expertise in support of product development. The ideal candidate is experienced in running ophthalmology clinical trials. S/he will work closely with our Clinical CRO to develop detailed plans, and manage the project activities, resources, budget and timelines to execute on project scope and milestones. The Clinical Project Manager will coordinate and manage the activities between the Clinical CRO, Clinical Trial Vendors, Clinical Sites and the Company’s internal team. This person must thrive in a fast-paced startup environment, be nimble to work on multiple activities simultaneously, and be motivated by the opportunity to learn new technologies.

Specific Responsibilities

  • Participate in establishing project plans, priorities, milestones, timelines and budgets to meet Company objectives;
  • Support business development activities by preparing presentations, updates and reports to Company members, Board of Directors and Industry Partners;
  • Develop and maintain relationships with strategic research, development and business partners as required for project needs.

Project Management and Development:

  • Serve as the lead Sponsor contact with outside organizations such as Study Sites, CROs, Central Laboratories and other contract organizations
  • Oversee the CRO contract activities including: (i) the development and execution of the project execution plan, (ii) site management and monitoring, (iii) clinical supply management, and (iv) budget
  • Responsible for Protocol Amendment preparation, documentation and tracking
  • Coordinate the site selection process in collaboration with CRO; responsible for ensuring effective communication between Sponsor, CRO and sites
  • Oversee CRO execution of start-up activities and ensure communication is optimized across all stakeholders
  • Coordinate planning and execution on Investigator meetings
  • Serve on core teams and provide clinical trial execution expertise
  • Identify and mitigate risks during the study; Communicate and manage risks around timelines during study execution
  • Oversee data collection and integrity in support of safety reviews and study reports
  • Ensure overall data quality and integrity and human subject protection by managing studies according to company standard operating procedures and regulatory requirements, including ICH GCP, CFR, EU Directive, HIPAA, as applicable
  • Write clinical SOPs

Education/Knowledge and Experience

  • A minimum of a Bachelor’s Degree or equivalent is required, preferably in medical/scientific field
  • Minimum 7 years experience in clinical research environment
  • Experience in successful initiation, execution and completion of drug and/or medical device clinical trials
  • Experience in ophthalmology clinical trials is preferred
  • Solid understanding of drug and/or medical device product development and the commercialization process
  • Experience engaging thought-leaders in clinical trial design and execution
  • Solution driven and flexible strategic thinker
  • Experience managing clinical trials subject to domestic and international regulations on conducting human subject studies
  • Experience managing a functionally and geographically diverse team
  • Strong verbal and written communication skills, ability to articulate compelling reports and presentations
  • Highly organized

Skills and Core Competencies

  • Excellent written and verbal communication skills;
  • Problem solving ability, creative and lateral thinking capability;
  • Ability to work independently and also bring team activities together;
  • Ability to work under pressure, within time/resource considerations to accomplish objectives;
  • Team player with excellent interpersonal skills;
  • Pragmatism combined with a positive, “can do” attitude;
  • Strength in balancing details and big picture
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