Principal Clinical Programmer

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

Position Title: Principal Clinical Programmer

Function/Department: Development Operations, Data Management

Reports to: Associate Director, Clinical Programming Or Director, Clinical Programming

FLSA Category (US ONLY): Exempt

Job Description

Position Summary: The Principal Clinical Programmer is a key member of the Development Operations, Data Management Team. This role will 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, 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 output.
• Advise clients on best practices for clinical database builds, eCRF layout, and compliance with CDISC standards.
• Mentor the study team in CRF design and specification development for leading EDC databases.
• Participate in evaluation of new technologies.
• Help to develop and implement processes and procedures, ensuring that processes and systems are aligned with corporate strategy and objectives.
• Participate in the interviewing process of Biometrics candidates as required for projects according to client needs.
• Perform other duties as assigned.
  
  

Managerial Requirements/

Responsibilities: Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.

Position Qualification

Requirements: Education: A 4-year computer science/math degree or equivalent; Master’s degree preferred. Experience:

• A minimum of 10 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#, preferred.
• 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. Required 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.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• 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.
  
  

Physical Demands (US

ONLY): Sedentary work that primarily involves sitting/standing

Acknowledgement: My signature below acknowledges that I have read the above job description and agree that I can perform the responsibilities and meet the requirements as presented. I understand this job description provides a general outline of job responsibilities and requirements and is not intended to be all-inclusive. I also understand that job responsibilities and requirements may