Position at a glance
| Item | Details |
|---|---|
| Position | Clinical Project Manager, IVD and Medical Device Studies |
| Function | Clinical Operations |
| Level | Project Manager |
| Employment type | Full-time |
| Employer | Hopkins MedTech Group LLC, doing business as Hopkins MedTech Compliance |
About the role
The Clinical Project Manager runs clinical performance studies for in vitro diagnostic (IVD) and medical device sponsors, from start-up through close-out. You are the sponsor's main contact and the person accountable for the study's timeline, scope and inspection readiness.
Studies at a CRO move quickly and involve several sites, a laboratory and a data team at once. The role suits someone who plans in detail and raises problems early.
Responsibilities
- Lead cross-functional study teams covering clinical operations, data management, biostatistics, regulatory affairs and laboratory partners.
- Build and maintain the project plan, timeline, risk register and communication plan, and report status to sponsors on an agreed schedule.
- Manage study start-up: site feasibility and selection, institutional review board submissions, site contracts, and site initiation and training.
- Oversee enrollment, specimen collection and shipment, monitoring visits, protocol deviations and query resolution.
- Keep the trial master file complete and inspection-ready throughout the study.
- Track scope and change orders, and manage vendors against agreed deliverables.
- Coordinate database lock, the clinical study report and the handover of study evidence to the regulatory submission team.
- Mentor clinical research associates and coordinators assigned to the study.
Qualifications
- Bachelor's degree in a life science, nursing, public health or a related field.
- At least 5 years of clinical research experience, including at least 2 years managing studies for medical devices or in vitro diagnostics.
- Working knowledge of ICH E6 Good Clinical Practice, ISO 14155 or ISO 20916, and 21 CFR Parts 50, 56 and 812.
- Experience managing sponsors, sites and vendors directly, and keeping a multi-site study on schedule.
- Clear written and spoken communication, and disciplined documentation.
Preferred experience
- Experience with IVD clinical performance studies for 510(k), De Novo or Emergency Use Authorization submissions.
- Experience with point-of-care or CLIA-waiver studies, or with specimen and biobank logistics.
- PMP, CCRP or CCRA certification.
- Experience in a CRO.
About Hopkins MedTech Compliance
Hopkins MedTech Compliance is an independent contract research organization (CRO) for medical devices and in vitro diagnostics (IVD). Operated by Hopkins MedTech Group LLC, a New Jersey limited liability company, we plan and run clinical performance studies and prepare the regulatory submissions that follow, for the United States (FDA) and the European Union.
How to apply
Send your CV and a short note naming this role (HMC-FT-04) to info@hopkinsmedtech.com, or use the contact page.
