The Sr. Clinical Programmer is responsible for clinical programming activities to support data management, data cleaning, data review and surveillance reporting activities for global projects, as well as management of external data specifications, reconciliation programming and effective oversight of external data vendors in partnership with the Data Management Lead.
Creates Data Validation Programs to identify missing and erroneous data.
Develop standard reports for measuring Key Performance and Quality Indicators (KPI, KQI: metrics) to determine study team and vendor effectiveness.
Produce ad-hoc reports to answer questions from medical, clinical operations, and data management.
Write reconciliation programs to compare data within different areas of the project database, and between the project database and other data sources (safety database, vendor data, etc.).
Perform validation programming in conjunction with the Statistical Programmer.
Perform Quality Control verification of Clinical Database Programmer clinical database setup and maintenance activities.
Serve as a backup for statistical programmer and clinical database programmer.
Manage electronic data from external data sources and vendors in partnership with the Data Management Lead. Liaises with vendors as needed to facilitate electronic data transfers and data specification requirements.
Write and/or review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards.
Generates safety surveillance and safety quality data review outputs as well as patient profiles for Drug Safety and Medical Monitors’ clinical data review
Provides leadership, training, guidance, and support to other department members on data review and data review tools
Collaborates with clients, peers, programmers, project teams, and requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs.
Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data).
Supports initiatives for Data Management, Clinical Programming and Safety/Clinical Data Review bridging activities, meetings, discussions.
Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
QUALIFICATIONS / REQUIREMENTS:
A minimum of a BS in Computer Science, Information Technology, or other related area
Typically requires a minimum 5 years hands-on relevant career experience in the pharmaceutical or biotechnology industry
Advanced technical expertise in Oracle Inform clinical databases software and supporting modules: Central Designer, Coder, etc.
Knowledge of external data sources (e.g. central labs, IXRS, ECG, eCOA), common data transfer options, and oversight of vendor file transfer/receipt
Excellent written and spoken communication skills
Highly skilled across multiple applications including proficiency in programming languages and tools, particularly: SAS, relational databases (SQL Server, Oracle, MySQL, PL/SQL, etc.), and Microsoft Office (Word, Excel, Outlook, PowerPoint, etc.)
Demonstrated problem solving abilities and strong organizational skills
Demonstrated proficiency with ICH, GCDMP, CDISC and GCP is required
Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment
Good project management skills and have demonstrated ability to develop processes and training
Solid understanding of clinical drug development processes is required
Previous people management experience is preferred