RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

The Clinical Project Manager is responsible for the successful planning, implementation, and execution of contracted activities. Responsible for functional area deliverables of all team members throughout the duration of each clinical investigation. Responsible for project timelines and managing financial health of assigned clinical investigation. Ensure clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by RQM+ and our sponsors. Supports the department Head as needed in the development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

Primary Responsibilities:

Responsible for all activities related to the coordination and management of pre- and/or post market clinical investigations from start-up through close-out
Partners with functional area leadership to ensure adequate resourcing and performance of the study team
Leads, mentors, and motivates project teams towards executing projects to their highest ability
Builds and maintains positive client relationships and serves as primary client contact
Ensures projects are completed in compliance with RQM+’s operational processes and within scope of contracted timelines and budgets
Maintains current knowledge of (EU) MDR 2017/745, (EU) IVDR 2017/746, ISO 14155, ISO 20916 and (EU) GDPR 2016/679
Serves as point of escalation for client and study team regarding study issues and/or needs for improvement
Reviews and identifies project study trends, developing appropriate early warning systems of potential obstacles and working with functional area leads to identify and evaluate risks, understand issues, and suggest and implement innovative solutions
Identifies, defines, and documents training requirements in learning management systems (LMS) and ensures project level compliance with study specific training requirements
Responsible for evaluation, client communication, and implementation of change management on all assigned projects
Manages vendors and associated deliverables per scope of work
Develops and manages study timelines and ensures timelines are met as per contract
Develops and manages study budget, including forecasts, review/approval of vendor invoicing, oversight of project utilization, and review/approval of unit billing
Develops and maintains project management documentation, including Project Management Plan, Risk Assessment and Categorization Tool, MS Project Timelines, monthly status reporting, etc
Identifies processes in need of updating and documenting to the direct line manager
Maintains client relationships for all assigned work, keeping project reporting current and ensuring executive management is aware of any performance risks
In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, work instructions, and related quality documents
Provides other project support to study team members, as required
Oversees delegation of support staff activities, as necessary
Assists in the development and delivery of capability and proposal defence presentations to prospective clients
Supports Proposals and Contracts with final project contract execution and change in scope documentation by the project team. Represents senior management in negotiation of contracts as appropriate

Requirements:

University degree in a health-related field or similar medical or paramedical background
Previous Project Management experience required
Several years direct clinical trial experience in a CRO or research-related organization preferred
Project management experience within the medical device, in-vitro diagnostic, SaMD development industry, with previous CRO experience, preferred
Previous or current experience in managing people within a scientific/clinical environment is required
Up to 20% travel may be required including international travel
Thorough knowledge of clinical research processes from First-In-Human studies to pivotal studies and post-market studies
Strong communication skills (verbal and written) to express complex ideas
Excellent and demonstrated organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Ability to manage multiple priorities within a variety of complex clinical investigations
Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
Ability to set baseline targets, track trends and implement mitigation plans
Understanding of basic data processing functions, including electronic data capture
Demonstrated problem-solving and financial negotiation skills
Excellent verbal and written communication and presentation skills required
Working knowledge of current ICH GCP guidelines
The ability to work independently, prioritize and work within a matrix team environment is essential
Working knowledge of Word, Excel, and PowerPoint required
Prior experience in electronic data capture and CTMS preferred

Behaviors:

Customer Focus, Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities

This position does not have supervisory responsibilities.

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 Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

This job operates in a professional office environment in a global organization. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch, or crawl.

We are committed to promoting equality of opportunity for all staff and job applicants. We aim to create a working environment in which all individuals can make best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit.

Our selection for recruitment does not discriminate based on age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, color, nationality, ethnicity, ethnic or national origin, religion or belief, sex or sexual orientation or gender reassignment status (protected characteristics).