Clinical Data Management Manager
Clinical Data Management Manager
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Data Management Manager for our client in Pennington, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- 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)
- 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 Client stakeholders (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.
- 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.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary