Job Overview :
The Senior Clinical Programmer (CP-Sr) supports clinical programming services. The CP-Sr creates, deploys, and maintains clinical databases and provides support to the study team as needed.
The CP-Sr provides technical and functional expertise in EDC and IRT systems, and where appropriate, mentors and supports other staff and peers on clinical databases.
Additionally, this role may provide input into protocols, budgets, contracts, and resource allocation at the request of the Clinical Programming leaders.
Job Duties and Responsibilities :
Design, manage, and maintain the clinical study database in keeping with the protocols and amendments, standard operating procedures (SOPs), good clinical practices (GCP), and other regulatory requirements.
Review system specifications and Data Validation Plan (DVP) and perform programming and configuration activities for assigned projects
Participate in release to production activities
Develop and implement validation procedures for clinical studies and their appropriate tests and documentation.
Generate listings for manual data review
Contributing to the Data Management Plan (DMP)
Communicate progress on programming milestones to management and other stakeholders
Identify and communicate problems and propose solutions regarding possible data quality issues
Deliver milestones in a timely fashion for assigned projects
Provide input to protocol writing and forms design process
Provide input to contract department
Coordinate clinical programming resources and activities together with group heads
Coordinate the activities of other Clinical Programmers providing support as necessary
Support less experienced Clinical Programmers
Identify process, standards, or system enhancements and contribute to their continuous improvement
Perform other tasks that are related to clinical programming, data analysis and reporting as assigned
Oversee the project including leading the project team, communication with the client, ensuring adherence to timelines and budget responsibility, if assigned the Project Manager role for a project where no clinical Project Manager is assigned
Supervision of more junior Clinical Programmers within the assigned projects.
Supervisory Responsibilities : No supervisory responsibilities
Job Requirements :
Education Scientific, Informatics, Mathematics or Medical Documentation degree
Experience At least 4 years of experience in design and deployment of clinical databases C#, SQL, and / or custom function programming (preferred) Medidata and / or Medrio configuration (preferred) Knowledge of pharmaceutical industry and data standards (preferred) Regular use of MS-Office, revision control system (e.
g. Subversion), and issue tracking software (e.g. JIRA)
Skills / Competencies Proficiency in MS-Office applications Good problem solving abilities (technical, interpersonal, decision making) Good communication skills (verbal and written) Good command of the English language Well organized and structured way of working Devoted to high quality work and sound understanding of documentation needs Ability to work in a team Good working knowledge of database programming (e.
g. Access, SQL, PL / SQL, XML) Good understanding of medical and laboratory terminology Good time management skills Delegation skills (both upwards and downwards)
Capabilities Ability to work remotely as applicable High level of working time flexibility to adjust to project flows