Principal Clinical Programmer

Principal Clinical Programmer

Job Location: India (Remote)

Job Overview: The Principal Clinical Programmer (CP-Pr) supports clinical programming services. The CP-Pr creates, deploys, and maintains clinical databases and provides support to the study team as needed. The CP-Pr 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: The specific job duties of a Principal Clinical Programmer may include but are not limited to:

• 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, correct, and develop 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
• Serve as the principal function specialist for the department for assigned projects.
• 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
• Drive process improvement initiatives
• 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.
• Interaction with external vendors in support of ongoing projects

Supervisory Responsibilities: No supervisory responsibilities

Job Requirements:

• Education
  • Scientific, Informatics, Mathematics degree preferred or equivalent combination of education and experience.
  • Advanced degree from a university or equivalent experience required
• Experience
  • At least 10 years of experience in design and deployment of clinical databases
  • Sufficient practical clinical trials experience
  • C#, SQL, and/or custom function programming (preferred)
  • Medidata, Veeva, 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