Clinical Research Project Manager (CONTRACTOR)

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.
Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.
We don’t make MedTech. We make MedTech happen.
The Clinical Project Manager role responsible for daily management of clinical research studies to support the company’s regulatory and legislative product approvals.  The position entails the clinical operation activities and the management of clinical studies in compliance with appropriate regulations and procedures.

Primary Responsibilities:

• Ensure that clinical trials are conducted in accordance with applicable regulations, IRB requirements, and company policies including maintaining a state of audit readiness.
• Liaison between Client, investigational sites, and CROs to coordinate and document clinical research studies including study start-up, attending team meetings, and managing the project timeline.
• Oversee project budgets, assessing invoice accuracy, budget change forms, accruals, monthly budget reports, and Sunshine Act reporting.
• Ensure the collection and management of essential documents for clinical studies.
• Generate protocol deviation forms as well as any associated assessments for CAPAs.
• Monitor the collection and analysis of clinical data.  Interface with applicable clinical research databases as necessary for research studies.
• Collaborate on clinical study reports based on expected timelines.
• Collaborate on monthly Newsletters for clinical Sites.
• Conduct basic statistical analyses for technical support of product line as needed.
• Conduct literature reviews and write research summaries related to product line.
• Evaluate and report on AEs, complaints, and failures associated with the product line.
• Assist with the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
• Review and train on appropriate Client SOPs for clinical research.
• Other assigned responsibilities as deemed necessary to meet project deadlines.

Requirements:

• Bachelor's or advanced degree in a relevant field required (i.e., Life Sciences, Pharmacy, Engineering, or a related discipline).
• Minimum 5 years of experience executing clinical research studies and/or relevant medical product development and testing experience.
• Demonstrate project management, critical thinking, and communication skills.
• Proficient knowledge of medical terminology.
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software - SmartSheets), project management techniques and tools; and web-based applications.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity VerificationAt RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careersEvery candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.