Clinical Data Manager (Study Start-Up)
Central New Jersey
W2 – US Based Applicants only
Contract / Office based
Multiple Opportunities to lead the technical Clinical Data projects to support the Study Start-Up initiatives for this leading Pharmaceutical client in Central New Jersey.
- Support the clinical data management start-up activities across one or more clinical development programs (planning, coordination, and delivery) to include high quality and reliable clinical trial data.
- Collect data requirements (eCRFs, ePRO, eCOA) from stakeholders for systems/applications. Maintain standards, user acceptance testing guidelines, and deliverables.
- Develop Data Quality Management Plan (DQMP) definitions and insure quality review of patient data to support regulatory filings, publications and other high-profile business activities.
Experience and expertise required:
- Bachelor’s degree required with an advanced degree preferred. At least 4 years of relevant industry experience.
- Project management certification (e.g. PMP) is desirable.
- Global clinical trial knowledge. Immuno-Oncology therapeutic experience is highly desirable.
- Knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
- Knowledge of database and dictionary structures (e.g. MedDRA, WHODrug).
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.
- A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.