Manager Data Management

Manager, Data ManagementLocation: Palo Alto, CAWork Arrangement: On-siteOur client is a biopharmaceutical company focusing in the Ophthalmology space. They are focused on bringing new science to the design and manufacture of next-generation retinal medicines with the goal of preventing and treating leading causes of blindness worldwide. Here you’ll have the opportunity to work alongside talented, cross-functional teams in an environment where scientific innovation, collaboration, and high-quality execution are highly valued.Currently they are seeking a Manager, Data Management to support clinical trial data management activities and help ensure the integrity, quality, and readiness of clinical data throughout the development process. This is an excellent opportunity for a hands-on data management professional who thrives in a collaborative, cross-functional environment and is motivated by the opportunity to contribute to innovative therapies for patients with retinal diseases.The OpportunityAs Manager, Data Management, you will play an important role in the execution of clinical trials, supporting database development, data quality oversight, vendor management, and preparation of submission-ready datasets. You will collaborate closely with internal teams and external partners to ensure clinical data is accurate, compliant, and delivered on time to support key study milestones and regulatory submissions.What You’ll DoSupport the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.Oversee data cleaning, query management and resolution, and delivery of high-quality datasets in support of clinical trial milestones and regulatory submissions.Partner with external data management vendors to ensure timely, high-quality deliverables and monitor performance against project timelines and quality standards.Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings, including NDA, BLA, and MAA submissions.Ensure data management activities comply with applicable industry standards and regulations, including GCP, FDA, and EMA requirements.Support audit and inspection readiness activities.Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, IT, and other cross-functional partners to facilitate effective data integration, review, and reporting.Contribute to the implementation, enhancement, and optimization of clinical data systems and tools, including EDC and data review platforms.Identify opportunities to improve data management processes, systems, and overall study execution.What You’ll BringBachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.7+ years of clinical data management experience within the biotechnology, pharmaceutical, or CRO industry.Hands-on experience managing study-level data management activities.Demonstrated experience working with and overseeing external data management vendors.Familiarity with clinical data management systems such as Medidata RAVE, Oracle Clinical, and/or Veeva.Knowledge of clinical data standards, including CDISC and SDTM.Experience supporting regulatory submissions is strongly preferred.Strong problem-solving and analytical skills, with exceptional attention to detail.Excellent organizational and project management skills, with the ability to manage multiple priorities and timelines.Strong written and verbal communication skills and the ability to collaborate effectively across functions. #J-18808-Ljbffr