Data Manager, Clinical & Video Evidence

Clinical Research · Boston, Massachusetts
Department Clinical Research
Employment Type Full-Time
Minimum Experience Mid-level

Red Nucleus is looking for a new teammate! We are hiring a Data Manager, Clinical & Video Evidence to join our Clinical Research team. This position can be based out of our Waltham, MA or Yardley, PA office. We also consider and encourage remote applicants for this role.


About Red Nucleus

Red Nucleus is the leading provider of strategic learning, performance, and process solutions for the life sciences industry. Our team is composed of more than 400 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space. At Red Nucleus, we work in an environment that fosters trust, self-expression, and the ability to excel in our careers. We are proud to have been recognized as one of the “Best Places to Work in PA” for all 4 years that we have been headquartered in PA.


About RN Clinical & iTakeControl

RN Clinical offers a comprehensive suite of real-world evidence services and tools: real world evidence planning, mobile clinical trial data, mobile learning and training for biopharma compliance, and open science, real world mobile health apps for patients. iTakeControl is the mHealth and mClinical tool suite from RN Clinical for biopharma and life science organizations.

The division is formed out of Shire and Genzyme leadership experience, with over two decades in genetic disease, rare diseases, and patient-centric education.

 

Summary

The Data Manager role focuses on creating, delivering, and overseeing clinical and patient reported data monitoring, including electronic data capture platforms, 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 Senior Director of Clinical and will have the opportunity to work with all members of the company and clients.


Responsibilities

  • Smart, talented and creative. Passionate about innovation and work to high standards.
  • Well organized, obsessed with details, and capable of juggling multiple projects.
  • Collaborative in a team environment but also confident learning and working independently.
  • Positive people and communication skills for interactions with our clients, vendors and study staff.
  • Ability to manage project schedules and effectively report and communicate progress.
  • Ability to manage vendors (budgets, project delivery, audits, qualifications) effectively.
  • 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.
  • 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.
  • 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 and/or support UAT of clinical data or ePRO systems.
  • Perform clinical and/or ePRO data review (including video data), query generation 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 transfer, 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.
  • Willing and eager to learn technology on iOS and Android applications.
  • Assist with resolving issues reported by users.

 

 Desired Qualifications

  • 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 (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.
  • Proficient in Microsoft Office applications including Word, Excel, PowerPoint, Teams.
  • Excellent written and oral communication skills.


Red Nucleus is an equal opportunity employer.


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  • Location
    Boston, Massachusetts
  • Department
    Clinical Research
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level