ClinClinicaLink
Project Manager II
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Company Information
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Project Manager II to join our Project Management team based remotely! The Project Manager II will be responsible for supporting their assigned projects and clients, managing all aspects of the project lifecycle, and interfacing with internal/external teams to execute flawlessly on project deliverables. The Project Manager II's responsibilities include:
- 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
- Disseminates 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
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Qualifications
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- 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
Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.
www.clinicalink.com
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