The Lead RaM Mapping Programmer (MP) is responsible for ensuring the timely and quality delivery of the Study Data Tabulation Model (SDTM) and Contivo mappings to ensure data migrate from the InForm™ Reporting database to the Clinical Data Repository (CDR) as specified. Collaborates with the Clinical Database Services (CDS) Developers, Global Clinical Data and Standards (GCDS), Technical Services (TS) and Biostatistics and Research Decision Sciences (BARDS) colleagues on technical requirements. Programs the SDTM mappings. Collaborates with the Clinical Database Testing (CDT) Analyst to ensure quality delivery. The MP acts as a point of escalation for any issues or delays to the timeline associated with SDTM Mapping, CDR Metadata Setup, CDR User Acceptance Test (UAT), Contivo, DMW and data flow to CDR. Also participate in CDPP (Clinical Data Platform Program) assignment development program.
- Assumes the responsibilities for Clinical database development deliverables including database set-up and edit check programming to support multiple clinical programs. Coordinates and participates in the following activities:
- Creates and develops clinical databases and data transfer files according to written specifications. Ensures adherence to clinical database standards, Standard Operating Procedures (SOPs) and Process Guidelines. Leads and participates in the review of Electronic Case Report Form (eCRFs) and edit checks, database development, programming of edit checks, and scripts to aid in the transfer of electronic data files.
- Oversees and coordinates clinical database activities for multiple clinical programs. Interface with RaM Mapping manager/supervisor to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group. Plans appropriately to ensure adherence to timelines. Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
- Trains new hires. Provide ongoing training and development to Clinical Database Developers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
- Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate RaM/CDS Mapping technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments. Provides technical and impact analysis support for change requests.
Education Minimum Requirement:
B.A. or B.S. degree, preferably in computer science, information technology, life sciences, or other healthcare-related disciplines. A Master’s degree is preferred.
Required Experience and Skills:
- Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
- At least 5 years of database development and Procedural Language-Structured Query Language (SQL-PL/SQL) programming experience
- Proficient in developing and supporting the Clinical Data Management System. Including experience with InForm, InForm Architect, Central Designer, DMW, XML, Java and Contivo.
- Good experience in Clinical Data Interchange Standards Consortium (CDISC) Standards (SDTM, CDASH, Define.XML), metadata, protocol, eCRF and SDTM controlled terminology especially in Oncology, Neurodegenerative diseases, Vaccines and other priority therapeutic areas such as Covid 19. Good knowledge in data dictionaries, libraries and Medical Device Reporting (MDR) etc.
- Solid knowledge of MS Windows/Office software and exposure to web-based applications.
- Ability to work independently, multi-task, and complete development activities in a highly dynamic, fast-paced work environment.
- Effective communicator (in written and verbal form) with proven ability to maintain productive, customer focused working relationships with both technical and non-technical areas.
- Possesses desire to continuously learn and innovate; has participated on cross-functional process and technology improvement initiatives.
- Possesses knowledge and understanding of clinical development, FDA regulations (21 CFR Part 11), and International Conference on Harmonisation Good Clinical Practice (GCP/ICH) guidelines.
Preferred Experience and Skills:
- Clinical database development experience preferred
- InForm Architect, Central Designer, Oracle Clinical, DMW, SQL, PL/SQL, C-Sharp