Project Manager II

Clinical Ink is a global life science company that combines data, technology, and patient science to enhance clinical discovery. They are seeking a Project Manager II to manage various aspects of clinical projects, ensuring timely and successful execution while serving as the primary contact for clients.

Responsibilities:

• Serves as primary point of contact for Clinical Ink customers, managing all aspects of the project lifecycle, including project scope, budget, delivery, change control, and reporting
• Will be responsible for overall management and oversight of large complex clinical studies and/or programs
• Develops and manages detailed project plan, including timelines, communication plan, training plan, data transfer plan and implementation plan
• Leads project kick-off meetings and facilitates the requirements gathering process with customers
• Ensures all functional leads and project team members understand their role and project requirements
• Coordinates internal project resources and third parties/vendors to ensure the flawless execution of projects
• Monitors and tracks project progress and provides project status reporting
• Ensures projects are delivered on-time, within scope and budget
• Delivers Investigator Meeting presentations that demonstrate solid comprehension of protocol and use of the Clinical Ink platform
• Conducts training sessions, as required, with site staff and monitors/CRAs
• Supports business development activities, including bid defense presentations, as required
• Disseminate all information from the customer accurately and promptly to all relevant internal stakeholders, ensuring any actions are understood and agreed with the project team as appropriate
• Mentors other Project Managers or Associate Project managers that are newly hired
• Performs other activities, as required, to ensure overall project and company success

Requirements:

• Bachelor's degree or equivalent experience
• 4 + years of relevant clinical trials experience within a Clinical Research Site, CRO or eClinical service provider in a project management role or other equivalent experience
• 2+ years project management experience required working on global projects and managing cross functional teams; includes demonstration of sole responsibility for project delivery
• Proven experience of managing multiple projects concurrently
• Experience working in data collection and management systems
• Demonstrates excellent verbal/written communication skills
• Working knowledge of software delivery lifecycle and methodology
• Working knowledge of GCP, ICH guidelines and relevant FDA regulations