Roles & Responsibilities :
- Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies
- Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules
- Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming
- Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
- Design "smart " listings and study-specific processes for effective data review, query issue and resolution
- Perform coding of adverse events, medical conditions and medications.
- Perform SAE reconciliation
- Lead and perform pre-lock and data lock tasks
- Prepare training materials and user guides for EDC data collection tools, deliver user training
- Design, generate, and review status metric reports, identifying and communication trends as needed
- Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
- Provide study specific training for team members and end users, as appropriate
- Lead large and complex projects
- Lead client and team meetings as required
- Interact with sponsors and manage vendors for complex studies
- Present at sales and marketing meetings for prospective clients
- Develop SOPs and manuals
Education & Experience :
- Minimum years of experience in Clinical Data Management
- Minimum BS in a scientific or health related field or equivalent
- Previous experience working for a CRO required
- Knowledge of medical terminology and pharmaceutical notation
- Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
- Excellent organizational and time management skills
- Strong collaboration and leadership skills
Associate Director, Program Clinical Data Management Lead
The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collabor...
Senior Manager, Clinical Data Management
Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Managemen...
Senior Manager, Clinical Data Management
The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Coordinate with Dire...
Clinical Data Management
Minimum years of experience in Clinical Data Management. Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming. Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receip...
Manager, Clinical Data Management
The Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in specific therapeutic areas to assure accurate planning and execution for data management results that meet Regeneron standards and within timelines. Supervising team for the initi...
Senior Manager, Technical Program Management, Bank Tech - Capital One
Center 1 (19052), United States of America, McLean, VirginiaSenior Manager, Technical Program Management, Bank TechAre you interested in leading programs that deliver on critical business goals and build large scale products & platforms?About Capital One: At Capital One, we’re changing banking for g...
Business Analyst with P&C Commercial Lines
NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. We are currently seeking a Business Analyst with P&C Commercial Lines to join our team in Warren, New Jersey (US-NJ), United States (US). NTT DATA is a $30 billion trusted global innovator of busine...
Manager, Learning Operations
Strong project management skills, with the ability to manage multiple concurrent projects and priorities. Strong project management skills, with the ability to manage multiple concurrent projects and priorities. Managing the logistics, resources, and operational support needed to execute critical pr...
Program Manager, PMO - Sun Pharmaceutical Industries, Inc.
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Area of Responsibility:Coordinate, Support & Align with Senior Program Leads on the Overall La...
Clinical Research Coordinator- Entry level
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forens...