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Research Project Manager Jobs
Company | Endominance |
Address | Washington DC-Baltimore Area, United States |
Employment type | FULL_TIME |
Salary | |
Expires | 2023-05-27 |
Posted at | 11 months ago |
Research Project Manager
Direct-Hire
Hybrid, Full-time
Washington DC-Baltimore Area
At Endominance, our mission is to develop transformative healthcare solutions which enhance the lives of people across the world.We combine biological, mental, and environmental factors to create future-proof healthcare solutions for those who need it most. If you’re passionate about contributing to scientific discoveries and are eager to work with a team who strives to help others pursue healthier, happier lives, we’d love to hear from you.
We are seekinga Research Project Managerto lead our team and manage our research endeavors.This position is currently remote, with the expectation of a flexible hybrid schedule within 6-12 months.
Position Summary:The Research Project Manager will oversee multiple studies, including the development, implementation, and execution of research activities in accordance with ICH guidelines, GCP, and FDA guidelines.
Responsibilities
- Oversees implementation of data management systems/platforms
- Monitors potential issues in data entry, protocol GCP, SOPs, and regulatory compliance.
- Prepares regulatory/ethics documentation as required by the FDA and other regulatory bodies.
- Ensures study objectives are met on time, within budget, and in accordance with protocol requirements, clinical research regulations, and quality standards.
- Drives all activities from start-up through close-out.
- Monitor and participate in the process of recruiting, screening, obtaining consent, maintaining, compensating, and the termination of study participants.
- Supports, trains, and manages internal team members.
- Understands the type/quality of data needed from a clinical trial and how it should be managed and presented.
- Interacts directly with IRB/FDA/Sponsors/Laboratory
- Participate in the development and maintenance of foundational study materials/tools (protocol with study design, informed consent, investigator brochure, CRFs, templates, SOPs, processes, etc.)
- Reports adverse events and protocol deviations.
- Facilitates regular meetings with the research team, PIs, Sponsors, and other project stakeholders.
In collaboration with Management…
- Present at conferences, webinars, or other marketing venues, as needed.
- Perform other duties as required or assigned.
- Collaborate on business development, recruitment processes, marketing, contracts/budgets.
- Network for opportunities to bring in new projects and partners.
- Supports publication plans and tasks.
- Creates and manages study tracking tools to ensure safety, efficiency, and compliance.
- Employs strategic thinking to identify problems and implement solutions.
Qualifications
- Clinical drug development experience is a plus.
- 3+ years of clinical research experience.
- Excellent with Excel, Microsoft applications, email, and web applications.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- 1+ years of management experience.
- Must be professional, respectful of others, and self-motivated.
- Well-developed written and verbal communication skills.
- Project management experience and a desire to see team members grow.
- Bachelor’s degree or higher.
- Independent problem solver who is detail-oriented, organized, and resourceful.
- Ability to work under minimal supervision.
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