Senior Clinical Database Programmer

The Senior Clinical Database Programmer /Lead Clinical Database Programmer will be responsible for performing/overseeing outsourced (and in-house) Database Programming activities as the Lead Clinical Database Programmer, to support client clinical trials worldwide. He/she will participate as an active

member of a multi-disciplinary team to assist with executing the Database Programming tasks required for phase 1-4 studies, study oversight and general data and document management. The Senior Clinical Database Programmer /Lead Clinical Database Programmer has a broad fundamental knowledge of the

database management and programming process and is able to perform key responsibilities independently and/or with minimal guidance.

• 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.
• Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred.
• 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.
• Experience with InForm and Medidata Rave is preferred.

Education and Qualifications:

• Bachelor's degree in Life Sciences, Biology, Pharmacy, Healthcare, Computer Science, or a related field.
• Advanced degree (Master's) preferred.
• At least 10 years of directly relevant work experience minimum
• Lead Clinical Database 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.
• Asist/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.
• This position requires 5% domestic and or international travel at the discretion of management.