Job description
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 Data Manager (CDM) is responsible for managing the day-to-day operations for data management studies for RQM+ and its clients. The CDM will work closely with the Manager of Clinical Data Operations in providing a proactive approach to data validation from initial set up, through maintenance and into locking / archiving the EDC database.
Responsibilities:
- Primary point of contact for Data Management at a project level, working closely with the Manager of Clinical Data Operations as well as the Cross Functional Project Manager assigned to the trial.
- Responsible for the development of the EDC database (including modules outside of EDC) for set up, including the testing of eCRFs and edit checks, user acceptance testing, collection of evidence following testing and overall documentation in the trial master file.
- Provides support and training to the wider Data Operations team as well as other internal/external parties as needed e.g. sites, sponsors, third-party vendors.
- Responsible for the development and maintenance of the Data Management Plan, Edit Check Specifications, eCRF Completion Guidelines and any other Project Specific Plans related to Data Management throughout the conduct of a trial.
- Leads Data Management teleconference calls/meetings and represents Data Management for global calls and meetings during a project.
- Creates and maintains specifications for listings and external data reconciliations.
- Develops of regular metrics reports and distributes them to RQM+ functional leads and sponsor organizations.
- Medical coding (MedDRA, ATC-WHO) if/as needed at a project level.
- Comprehensive review of the data entered through ongoing listings and reconciliation activities, resolving all noted issues, querying as needed and tracking any trends in the data.
- Oversight of all Data Management trackers and documents to support a proactive approach to data cleaning.
- Responsible for reviewing queries and resolving them throughout the trial.
- Creates Data Management Listings via SAS programming.
- Provides adequate sponsor oversight to data management CRO´s or external data providers (e.g. for ePRO data, laboratory data)
- Ensures EDC user access is reviewed on an ongoing basis aligned with RQM+ SOPs.
- Acts as a subject matter expert for the assigned EDC platform needed at a project level.
- Supports timelines development and maintenance in set up, maintenance and database lock phases.
Requirements:
- Academic background in Science or Biomedical Engineering.
- Previous Data Management experience for a CRO or in industry – preferably for a Medical Device / Diagnostics company.
- Good working knowledge of ICH GCP.
- Proficiency in using multiple EDC platforms.
- Strong communication and organizational skills.
- Working knowledge in setting up databases in EDC platforms that may use modules outside of EDC such as Randomization (or RTSM), Labs, ePRO, eConsent, Imaging, and Adjudication amongst others.
- Working knowledge of SAS and/or SQL programming.
- Experience working in set up, maintenance and locks for multiple projects in parallel.
- Working knowledge of MedDRA and WHO DD Coding.
- Excellent levels of communication and organizational skills.
- Proficiencies in working independently as well as within an overall team structure.
Behaviors:
- Customer Focus, Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Decision Quality, Informing, Integrity & Trust, Planning & Organization.
Supervisory Responsibilities:
- This position does not have supervisory responsibilities but may mentor/train more junior associates as needed.
Work Environment/Equal Opportunity:
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, colour, nationality, ethnicity, ethnic or national origin, religion or belief, sex or sexual orientation or gender reassignment status (protected characteristics).
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:
All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
Every 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.
