The Associate Director, Data Design and System assists the Senior Director, Data Science Excellence and Innovation with clinical data captured system design, setup and maintains in support of SDP Oncology studies across all stages of clinical drug development. The incumbent ensures that clinical data capture, systems, and processes represent accurate, consistent, high quality, and reliable data capture, storage and sharing. Additionally, the incumbent impacts multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
- Work collaboratively with Clinical Data Management and IT to maintain and administer Clinical Data Management Systems, providing system implementation administration support, managing permissions and security, making recommendations for enhancements, and managing the roll out and validation of system updates.
- Work closely with key SDPO functional lines (Data Science, Clinical Operations, Clinical Development, etc.) to provide optimal business use of technology as well as defining and implementing clinical study metrics, data review tools and data visualization capabilities.
- Provides input regarding project resource requirements related to system implementation and data analytics.
- Stakeholder in Data Standards team to provide technical expertise on implementation of SDPO standard via global library, including eCRF, data validation and data entry guideline.
- Provide oversight to vendor for implementation of GRACE within SDPO as the GXP compliant data repository and clinical data computation platform from clinical data system integration, external lab data ingestion to data mapping to standard format.
- Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards.
- Assist Sr. Director with oversight and management and mentoring responsibilities for contracted staff.
- Contributes to the strategic oversite of clinical programs and individual SDPO sponsored trials.
- Contributes to departmental process improvement, standards, and integration of technology.
- Mentor and coach junior staff.
- Other duties as assigned.
- Bachelor of Science (or equivalent degree) in a scientific or allied health field.
- 8-10 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background.
- Prior experience with Clinical Data Management Systems is highly preferred.
- Experience working as a liaison between IT and Clinical or Data Science.
- Understanding of clinical data and how to present the data in a meaningful way.
- Experience in EDC required (Medidata Rave preferred). Experience with other clinical trial source systems such as CTM, IRT, ePRO/eCOA is highly preferred.
- Working knowledge and experience of IT systems lifecycle and formal SDLC methodologies, particularly business and functional requirements analysis.
- Experience with Life Science systems and knowledge of pharmaceutical regulations including 21 CFR Part 11 required.
- Experience with data interfaces, and specifically clinical data interfaces and data exchanges with CROs and other clinical trial vendors.
- Working knowledge of data modeling and data architecture skills.
- The candidate must be a good listener with strong communication, presentation, and interpersonal skills.
- Ability to analyze facts and solve problems.
- Adaptable to multiple demands, shifting priorities, ambiguity and rapid change.
- Ability to effectively collaborate in a dynamic environment.
- High level of proficiency in analytical and data visualization tools such as Spotfire, J-review, SAS, desired.
- Working knowledge of medical and statistical terminology.
- Understanding of validation process for applications.
Job Location: Cambridge, MA
Equal Opportunity Employer
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