Description

Job description:

As a Clinical Project Manager, you will manage multiple aspects of clinical operations for assigned clinical trials/product lines to assure the highest standards of clinical study execution. You will be responsible for managing all aspects of a clinical trial or multiple clinical trials (such as IDEs, Investigator Initiated Trials, Post-Market Clinical follow-up, etc.) including CRO & vendor selection and oversight to ensure patient safety, adherence to the contract, protocol and appropriate safety regulations and data integrity. You will ensure compliance to SOPs, organize and lead CRO/vendor meetings, maintain study timelines, and provide study updates to internal line functions and management team.

Leads the end-to-end management of clinical studies for Class III medical devices, from feasibility assessment to study close-out.

Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.

Manages Contract Research Organizations (CROs), imaging vendors (Core Lab), and other third-party service providers, including scope definition, performance oversight, and delivery of milestones and project deliverables.

Serves as primary contact and resource for CRO and vendor personnel. Supports selection and provides oversight and management of consultants and vendors.

Tracks and reports on the progress of assigned clinical trials including budget and timelines.

Develops project plans and ensures adherence to budget and timelines.

Executes project plans including management of schedule, cost, resources, and deliverables (e.g. protocol, database development, reporting).

Collaborate with various teams (including Clinical Research Associates, Data Management, Biostats) to create and manage study related documents.

Oversees data management and analysis to ensure quality of clinical trial data.

Oversees data clarification process as needed to insure database lock according to agreed timeline.

Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.

Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.

Ensures appropriate oversight of CRO and vendors.

Organizes and participates in meetings – i.e. Internal Study Core Team Meetings, Investigator Meetings, meetings with KOLs to discuss project proposals, meetings with contracted vendors.

Provides regular and ad-hoc written and verbal project updates to leadership and ensures effective communication within the study team.

Leads the preparation of clinical documents in support of regulatory requirements including IDEs, IDE and IRB annual updates, briefing documents, Clinical Trial Agreements, as requested.

Provides input and review of the development of in-house operations SOPs, guidelines and systems.

Develops and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators).

Demonstrates thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Phenox SOPs and policies.

Proactively identifies risks and leads team members to mitigate risks in timely fashion.

Manages the triage of clinical site questions to appropriate team members (Program Manager or Director as appropriate).

Prepares and manages clinical trial site budgets.

Demonstrates experience with contract review and budget negotiations.

Qualifications

Education & Experience

Bachelor’s degree in life sciences, nursing, engineering, or a related field required; advanced degree a plus.

A minimum of 6 years of clinical research or clinical trial management experience.

Experience working directly with medical devices (Class II/III strongly preferred).

Direct experience managing IDE studies, post-market trials, or investigator-initiated trials.

Demonstrated experience managing Contract Research Organizations (CROs), Core Labs, and other third-party vendors, including contract and budget negotiation.

Knowledge & Skills

Solid working knowledge of GCP/ICH guidelines, FDA regulations, and the IDE/IRB submission and reporting process.

Strong project management skills – scope, budget, timeline, and resource management.

Comfortable negotiating vendor contracts and managing site budgets.

Strong written and verbal communication skills with the ability to clearly present information to leadership, Key Opinion Leaders (KOLs), and investigators.

Highly organized with ability to manage multiple studies and competing priorities at once.

Proficient with clinical trial management systems (CTMS), EDC systems, and standard MS Office tools.

Preferred

Experience in neurovascular, interventional, or cardiovascular devices.

PMP, ACRP (CCRA/CCRP), or SOCRA certification.

Experience with multi-site and global clinical trials.

Comfortable in a smaller or growth-stage medtech environment, with the flexibility to take on a broad range of responsibilities.

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: In person

Requirements

Key Requirements:

End-to-end clinical study management experience, from feasibility through closeout
Vendor Management/Oversight experience (CROs, Core Lab, Translation)
Minimum 4-6+ years of clinical research experience; Medical Device preferred
Based in the USA; Open to across the US but preferably East Coast
Contract and budget negotiation experience (for Clinical Trial Agreements/site study budgets)
Strong organizational and communication skills

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