Job Title: Clinical Data Management Manager
Job Location: Pennington, NJ 08534
12 + months Contract
- The Manager, Clinical Data Management (Study Start-Up) is a role considered essential to the sustainability and success of the client R&D pipeline. This role reports to the Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Clinical Operations (GCO).
- This is an office-based position located in Central New Jersey, USA or Braine-l'Allaud.
Specifically, the Manager, Clinical Data Management (Study Start-Up) is accountable for:
- Providing support to clinical data management start-up activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
- Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.
- Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g. ePRO/eCOA) to ensure quality and timely deployment.
- Creation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various clientclientstakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities.
- Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.
- Participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.
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.
- An understanding 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.