Remotehey

Job Title : Clinical Project Manager

Location : Remote

Pay range : $70 - $73/hour

Contract : 1 year

Clinical Project Manager

(Medical Device Clinical Studies)

Position Summary

The Clinical Project Manager is responsible for leading and executing medical device clinical investigations across the full study lifecycle—from study design and start-up through closeout and reporting. This role ensures operational excellence, regulatory compliance, inspection readiness, and high-quality clinical data generation to support product development, regulatory submissions, and post-market clinical evidence needs.

The Clinical Project Manager leads cross-functional teams, oversees CROs and vendors, manages timelines and budgets, and drives study execution to meet strategic and regulatory objectives.

Key Responsibilities

Study Planning & Start-Up

• Lead study feasibility activities, including site identification, qualification, and selection.
• Contribute to the development and review of study documentation (e.g., investigational plan/protocol, informed consent forms, monitoring plans, study manuals, CRFs, EDC inputs).
• Coordinate start-up deliverables including vendor selection and oversight, contract support, IRB/EC submissions, site activation, and investigator training.
• Partner with Medical Affairs and Regulatory Affairs to support clinical sections of U.S. and international regulatory submissions.

Study Execution & Oversight

• Provide end-to-end operational oversight of multi-site clinical studies.
• Manage CROs and vendors to ensure adherence to scope, quality, timelines, and budget.
• Track enrollment, milestones, and deliverables; proactively identify risks and implement mitigation strategies.
• Lead governance meetings and cross-functional communications.
• Prepare dashboards, study updates, risk registers, and executive-level summaries.

Quality, Compliance & Inspection Readiness

• Ensure studies are conducted in accordance with GCP, applicable regulatory requirements, and internal SOPs.
• Oversee TMF/eTMF completeness, documentation quality, and audit/inspection readiness.
• Track protocol deviations and noncompliance events; support investigations and CAPA development as needed.
• Coordinate with Quality and Medical Safety teams regarding safety reporting, reconciliation, and trend monitoring.

Data Review & Clinical Evidence Support

• Coordinate review of clinical data outputs and support data cleaning activities.
• Contribute to interpretation of clinical data with internal stakeholders.
• Support development and review of clinical study reports (CSRs) and regulatory documentation.
• Compile post-market clinical information to support lifecycle management and regulatory submissions.
• Collaborate on documentation for the Design History File (DHF) and other regulatory filings.

Additional Responsibilities

• Support corporate clinical initiatives and other company-sponsored clinical activities as required.

Qualifications

Education

• Bachelor’s degree in Life Sciences or related field (or equivalent combination of education and experience).

Experience

• 5+ years of clinical research experience in medical devices or pharmaceuticals.
• Minimum 2+ years of direct project management experience preferred.
• Experience managing CROs, vendors, and multi-site clinical studies.
• Experience with medical device clinical investigations and IRB/EC processes required; IDE experience preferred.
• Experience in endocrinology or diabetes is highly desirable.

Skills & Competencies

• Strong operational project management skills with the ability to drive execution across multiple workstreams.
• Solid understanding of GCP, regulatory guidelines, and quality requirements.
• Proven risk management and problem-solving capabilities.
• Excellent written and verbal communication skills; able to effectively engage stakeholders at all levels.
• Strong analytical skills and attention to detail.
• Proficiency in Microsoft Office applications and familiarity with clinical systems (e.g., EDC, eTMF).
• Collaborative, adaptable, and able to thrive in a fast-paced, cross-functional environment.

Travel

• Approximately 10% domestic and international travel.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.