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 Science Lead is responsible for leading the day-to-day execution of clinical data management activities at a project level. This role ensures high-quality, inspection-ready data through proactive planning, hands-on execution, and collaborative engagement across cross-functional teams and external vendors. The Clinical Data Science Lead plays a critical role in the successful delivery of clinical trials by owning the database lifecycle from design through final database lock.
Responsibilities:
- Provide day-to-day operational support for clinical data operations activities across all studies assigned.
- Lead the design of the Case Report Form (CRF) in both paper and electronic formats, ensuring alignment with protocol requirements as well as sponsor/RQM+ standards.
- Oversee development of eCRF modules (e.g., randomization, adjudication, ePRO, eConsent and inventory/trial supply) and system edit checks within selected EDC platforms.
- Draft and finalize the Data Management Plan (DMP) and eCRF Completion Guidelines (eCCG), collaborating with RQM+ functional/sponsor leads.
- Create and execute User Acceptance Testing (UAT) scripts; coordinate UAT activities to ensure system readiness for Go Live.
- Ensure that the database is stable and ready to ‘go live’ ahead of First Patient In (FPI).
- Maintain and track deviations from the DMP through comprehensive documentation in the Data Management Report (DMR).
- Create, validate, and maintain Data Management Listings for ongoing review and cleaning of clinical trial data.
- Generate and deliver routine status reports and data summaries to study teams and management.
- Monitor data trends and site performance using oversight listings; performing targeted reviews to identify and address data quality issues.
- Review and manage EDC user roles and access throughout the study, coordinating with clinical operations to maintain compliance and access control.
- Support query resolution activities and ensure timely cleaning of clinical data.
- Provide independent support to other projects enabling a quality review audit of data by examining closed queries/sample number of subjects/listings to ensure that data is being validated accurately throughout the course of the study.
- Support the development/deployment of the clean patient tracker and use in the context of batch cleaning as a proactive means of cleaning data ahead of major deliveries such as interim analyses/database lock.
- Ensure all data entry, cleaning, documentation, coding, reconciliation, and issue resolution are complete before database lock.
- Archive and transfer study data in accordance with RQM+/Sponsor SOPs.
Requirements:
- Bachelor’s Degree or Master’s Degree in Science, Biomedical Engineering, Life Sciences, or related field.
- Minimum of 5 years of relevant experience in clinical data management or data operations within the pharmaceutical, medical device and/or CRO industry.
- In-depth knowledge of ICH-GCP, FDA/EMA data regulations, as well as data privacy regulations (GDPR, HIPAA).
- Strong interpersonal and communication skills, with ability to effectively collaborate across disciplines and with external partners.
- Proficiency with multiple EDC systems including (but not limited to): Mednet Solutions, Medrio, Zelta, ClinInfo, and SecuTrial.
- Familiarity with SAS for data review is a bonus.
- Working knowledge in setting up databases in EDC platforms that may use modules outside of EDC such as Randomization, Adjudications, ePRO, eConsent, as well as Inventory/Trial Supply.
- 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 including the use of MS Project for the creation and maintenance of timelines.
- Proficiency in working independently and performing effective oversight of DM operations, supporting and training the team as needed.
Behaviors:
- This position requires attention to detail, problem-solving capabilities, and a strong understanding of clinical data standards, EDC functionality, and regulatory requirements.
Supervisory Responsibilities:
- This position may mentor more junior team members but does not have official line management responsibilities.
Work Environment/Physical Demands
- 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.
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.
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).
