Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• Works with and has hands on experience of clinical data management systems like Medidata Rave & Veeva Vault and provides technical leadership in data management activities and deliverables including, but not limited to, database development and data validation. Serves as the lead programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines. Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.
• Independently performs tasks following within the timelines established by the team, in accordance with the process outlined in the departmental procedures and indicated by the project contract.
• Technically strong in Medidata Rave & Veeva Vault EDC systems to handle any complex level of study requirements
• Expertise in handling Global Libraries by following SDTM Standards.
• Designs, builds, and tests project databases & edit checks, Strong in Custom Functions.
• Should be able to lead multiple studies and clients based on need, and should be agile and adaptable for any new tools per project needs
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Research and leverages resources to resolve issues and manage complex tasks through the development and application of new knowledge and/or professional skills in areas including programming and technology and leadership of project team in delivering tasks.
• Assumes leadership responsibility and technical leadership, demonstrating a good understanding of the role in the overall process.
• Trains, mentors, and coordinates the activities of junior programmers and peers.
• Participates in departmental or corporate process initiatives.
• Contributes to the creation and validation of reporting tools / standard applications / enhanced processes, and works with IT in troubleshooting, reporting, and resolving system issues.
• Provides input on bidding process and SOP development.
• May increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• 5+ years of working experience as EDC programmer
• Should have working experience in Medidata RAVE or VEEVA
• Should have experience in Edit Check, Custom Functions and other clinical programming related activities
• Strong written, verbal and computer skills
• Demonstrated leadership skills and the ability to work and communicate effectively on a multidisciplinary team with a positive attitude, enthusiasm toward work, and capable of mentoring and working well with others
• Demonstrated organizational and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Proficient in one or more programming languages
• Proficient in relational database systems (RDBMS) and structure
• Proficient in programming tools C#, SQL, Crystal Reports, Spot Fire and JReview
• Strong presentation, interpersonal, and problem solving skills
• Capable of attaining, maintaining and applying a working knowledge of GCPs and applicable SOPs
• Demonstrated ability to make recommendations for process development and improvement
• Demonstrated skill in identification and resolution of technical problems in a professional environment