Job Description

Position Summary:

The Senior Clinical Programmer is a key member of the Clinical Development Operations, Data Management Team. Senior Clinical Programmers program standard and study specific electronic Case Report Forms (eCRFs), edit checks, data displays, and reports in accordance with approved Database Specifications, Data Management Plans (DMP), Data Transfer Specifications (DTS) and Data Review Specifications (DRS). Set-up study specific mapping for WHO-Drug and MedDRA dictionaries. Provide lead clinical programming support for data cleaning in clinical trials based on Standard Operating Procedures (SOPs) or study specific guidelines. 

Position Responsibilities/Accountabilities:

• Serve as the clinical programming lead on project teams as EDC Subject Matter Expert and perform training.
• Program standard and study specific electronic Case Report Forms (eCRFs) edit checks and data displays and reports.
• Set-up study specific mapping for WHO-Drug and MedDRA dictionaries.
• Ensure the efficiency, quality, and integrity of database development, reporting and project activities.
• Perform data checks as needed to ensure integrity and correctness of data displays and to understand structure and content of data.
• Perform QC/validation of vendor datasets, clinical data listings and edit checks to verify the output.
• Advise clients on best practices for clinical database builds, eCRF layout, compliance with CDISC standards.
• Mentor the study team in CRF design and specification development for leading EDC databases.
• Perform other duties as assigned.

Managerial Requirements/ Responsibilities:

Position may have management responsibilities.  Development, oversight, and direction of departmental staff which may include interviewing, training, personal growth, retention plans, performance management and goal setting.

Position Qualification Requirements:

Education:

• A 4-year computer science/math degree or equivalent; master’s degree preferred.

Experience:

• A minimum of 7 years of relevant work experience, including programming experience with Clinical Database Management Systems, i.e., Medidata Rave, Medrio, IBM, etc.; SAS experience a plus.
• Custom Functions programming experience using C#.
• Previous experience in pharmaceutical research or CRO setting required.
• A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.

Required Certifications: Certified Medidata Rave Study Builder, preferred.

Required Skills:

• Excellent verbal, written, and interpersonal skills.
• Extensive knowledge of clinical trial study design.
• Able to work independently on multiple, concurrent projects.
• A high degree of accuracy and attention to detail.
• Can attend study team meetings as needed.
• Proficient with Microsoft Office Suite.
• Strong organizational, problem-solving, and analytical skills.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Commitment to excellence and high standards.
• Ability to interact across operational areas as required.
• Ability to interact with sponsor representatives as required.
• Ability to travel for meetings or training activities may be required.