Atorus · 2 months ago
Principal Medidata RAVE Programmer
Radnor, PA
Contract
Onsite
Lead/Staff
10+ years expAtorus is seeking a Principal Medidata RAVE Programmer responsible for overseeing database programming activities to support client clinical trials worldwide. The role involves managing relationships with CROs, designing eCRFs, and ensuring compliance with regulatory guidelines while working independently and leading a multi-disciplinary team.
AnalyticsInformation TechnologyPharmaceutical
Responsibilities
Principal Programmer to manage and monitor the progress of clinical database programming activities (with minimal oversight) with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
Ability to manage (complete database tasks), track and oversee CRO responsibilities for overall performance management and provide updates to Head of Data Management
Senior Clinical Database Programmer Responsible for designing the eCRF in leading EDC systems in Medidata Rave
Technical expertise, technical writing ability, and proficiency in Systems Development Life Cycle (SDLC) principles
Provide technical support and troubleshooting for Medidata Rave study development as well as site management and user access within supported iMedidata modules and applications
Serve as system administrator to grant user access using iMedidata Cloud Administration for Rave EDC, Coder, Lab Admin, RTSM and Safety Gateway provide Oversight, guidance, and design of study build activities on Medidata URL
Create Advanced Analytics dashboards
Insights into creating actionable dashboards and deep understanding and knowledge of good interpretation of clinical data
Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency
Responsible for conducting Quality Control of study design for assigned projects and participate in the validation of EDC studies
Responsible for the creation and maintenance of library objects within the Standards and Global Libraries
Responsible for ensuring compliance of standard objects usage throughout the business
Responsible for the management of standard objects within the Standards and Global Libraries
Perform all activities related to specification development for study build and design of databases according to Standard procedures
Responsible for the review and approval of derivations and edit checks requested by the project teams
Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
Complete work according to client SOPs, Work Instructions and project specific guidelines in accordance with Good Clinical Practice
Able to perform independently and/or oversee and be accountable for Data Capture (EDC) systems testing, upgrades, migrations, report production and query management and or CRO (in collaboration with lead data manager) according to company standards
Participate in clinical study teleconferences and in person meetings to represent data management and provide respective study updates
Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs) for study conduct, metric development, and trend monitoring in support technology
Develop and review transfer agreement (DTA/DTS)
Ability to creating, update, and issue data management study specific documentation in line with study activities
Manage study build process including writing, proofing and assisting with data build specifications
Extract and analyze clinical data using data visualization tools, SAS data listings and or other outputs regularly to identify trends and/or issues to be communicated and addressed with CRO to support client study oversight of CRO activities for regulatory compliance
Ability to manage and implement new data management processes, guidelines and SOPS within your study team and organization
Manage, participate and be accountable for the work responsibility deliverables of the assigned DM study team
Submit and manage study escalations related to poor vendor performance
Ability to provide site and/ or study team training
Develop, deploy and manage a be accountable for EDC timelines for milestone data deliveries
Oversee study review practices for study team adherence
Assist/Own department management and process development of data review and export tools
Assist/Own department with development of standards (processes, database, system etc.)
Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors during all phases of conduct of a study to meet defined department goals
Able to review and provide feedback to CROs or study team on other study related documents related to or that have impact to data management related activities. (e.g. Clinical Monitoring plans, Statistical analysis plans and third party data transfer specs etc.)
Able to review and provide feedback on STDM datasets, formats, mapping
May aid or provide training to internal study team members on Agiloft and/or Netsuite processes
Responsible for department processing of contracts and invoices
Perform occasional data review activities of clinical data and/or external data, to help support lead data manager in high quality oversight of data cleanliness and associated activities
Lead the data management oversight of the TMF, with the CTM, maintenance of data management files and perform consistent quality checks of the TMF to ensure data management related documents are filed in a timely manner to maintain regulatory compliance
Assist in the database lock and freeze activities per SOPs and timelines
Develop or assist with the development of workflow processes and work instructions, improving the efficiency of data management activities at client
Qualification
Required
Significant track record in Database programming for the pharmaceutical/biotechnology industry, or CRO, as a Lead Clinical Database Programmer
Has good project management skills and a proven ability to multitask
Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Database Programming tasks and interact with vendors
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
Attention to detail and the ability to work independently and/ or within a multi-disciplinary team, as well as with external partners and vendors
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications
Prior experience with different Database Programming systems and technologies, and Electronic Data Capture systems
BA/BS, preferably in the scientific/healthcare field
At least 10 years of directly relevant work experience minimum
Preferred
Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred
Experience with InForm and Medidata Rave is preferred
Company
Atorus
Atorus is a pharmaceuticals and clinical analytics service-based company.
201-500 employees
H1B Sponsorship
Atorus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Mark Penniston
Chief Executive Officer
Recent News
2024-10-18
Company data provided by crunchbase