RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Senior Manager provides strategic guidance and support to maintain the Data management and physical infrastructure, its configuration, performance, and storage requirements. Their duties include the ownership of developing systems, procedures, and policies for data management in an organization, assisting colleagues in performing data-related tasks.
Primary Responsibilities
- Contribute to data management activities in support of Alnylam clinical studies, including eCRF development by leading cross-functional reviews of eCRF content.
- Establish database build activities, including review of edit check specifications and performance of user acceptance testing.
- Monitor data collection, remote and source data verification (SDV), coding, and cleaning by vendors through tracking of study metrics and targeted data reviews.
- Oversee database lock activities and ultimate archiving of study data.
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Product Safety; CROs, central and local laboratories, and other vendors.
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews.
- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation.
- Ability to manage junior data managers within a functional team structure.
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
- Support GCP inspection readiness
Requirements
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 5 years related experience in a medical
- Experience with global studies, utilizing an outsourced CRO model.
- Experience in clinical MedTech and drug development through concept to post-approval
- Education or work experience in a health-related field
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems.
- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH
- Experience working with multiple EDC platforms.
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MS Office Suite (Excel, Word, and PowerPoint) and familiarity with MS Project
- Excellent written and oral communication skills
- Highly motivated and flexible, with excellent organizational and time management skills.
- Ability to work independently and as part of a multi-disciplinary team
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 and applicable ISO and CFR regulations
Behaviours
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
Supervisory Responsibilities
- This position may 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: 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.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).Apply for this job
