iTakeControl is a boutique firm for patient-centric research services and innovative clinical design to serve genetic diseases and personalized medicine for the biopharma and life science organizations. We offer a comprehensive suite of tools and services: mobile clinical study data collection specializing in video capture and ePRO collection, study management portal access for central rating of video data assessments, clinical registry support, clinical data capture, and consulting services for clinical operations support and governance. The company is formed out of Shire and Genzyme leadership experience, with over two decades in genetic disease, rare diseases, and patient-centric education. We are based in Boston MA, with staff and clients across the US.
The Data Management role focuses on creating, delivering, and overseeing clinical and patient reported data monitoring, including video evidence, data quality, and database integrity for research studies. This will include following and establishing study specific or company level SOPs for data collection and review, the design, implementation, and testing of systems for data capture and review, such as EDC, ePRO, or other data acquisition methods, and conducting data review for studies under their purview. The role will be supervised by the Clinical Operations Lead and will have the opportunity to work with all members of the company and clients.
- Support innovation in medical data acquisition and GCP-quality research data, including video collection for clinical trials, knowledge of EHRs, data standards, and data mapping processes.
- Lead the development of clinical data management services, deliverables, client-facing and internal documentation, such as eCRFs, edit check specifications, AE/SAE plans, coding plans, data monitoring plans, and vendor data specifications.
- Maintain client relationships in alignment with the lead project manager by leading delivery for clinical data deliverables, including communications, meetings, and specification reviews with cross functional team(s).
- Lead UAT of clinical data or ePRO systems.
- Perform clinical and/or ePRO data review (including video data) and data reconciliation.
- Project manage data management activities.
- Design and oversee filing and documentation of data management documents (eTMF).
- Support GCP quality programs, with both internal and client study specific SOPs, where appropriate.
- Refine internal Quality Management System to support innovation updates as necessary.
- Manage data export, extraction, migration process as needed per client requirements.
- Lead and/or participate in novel, innovation, or process change initiatives.
- Explore options for remote data monitoring of research site source data.
- Bachelor’s degree, or advanced degree in health-related field and/or computer science.
- 5 to 7 years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
- Hands-on experience designing and building clinical EDC systems (Medidata Rave, RedCap Cloud, or similar).
- Experience with data reporting and extract processes to support sponsor reporting.
- Experience with writing and implementing SOPs and processes.
- Knowledge of, and experience with clinical and health data standards (e.g. CDISC/CDASH/SDTM/FHIR/OMOP) as well as medical terminology and medical coding dictionaries including MedDRA and WHO Drug.
- Experience working with central or specialty labs/vendors.
- Experience with study amendments, observational research, registries, and data migrations.
- Knowledge of GCP, ICH, HIPAA, GDPR, and FDA requirements for human subject research and their application to clinical data management.
- Comfortable in a small, dynamic, and virtual company environment, with strong attention to detail, problem-solving skills, and strong interpersonal skills for internal and client relationships.
- Experience with clinical drug development pathways, including Phase 1-3 studies.
- Would value experience with issues related to rare genetic diseases, gene therapy, and long term follow up challenges.
- Knowledge of, and experience with Microsoft applications including Word, Excel, PowerPoint.
- Excellent written and oral communication skills.
- Must be 18 years or older.
- Must have an undergraduate degree from an accredited University.
- Based in Philadelphia, Boston, or eastern US.
- Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
- Fully remote, can reside anywhere in the US
Available for meetings and calls during most EST hours.
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.