Job Description

Assist in the development and implementation of solutions to global technical service issues and concerns regarding EDC or SAS or other proprietary software, including proactive prevention strategies. Develop/validate Custom/Complex SDTM/SAS datasets/Listings/reports. Efficiently handle external data and data reconciliations. Responsible for configuration and implementation of EDC services within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data. With some support act as technical liaison with project team members, clients, and Data Managers to drive the technical aspects of project delivery.

Summary of Responsibilities:

• Expected to assist with leading EDC Builds and mentor the study team in setting up Medidata RAVE or Oracle InForm or SAS or other proprietary software.
• Lead the development of visual analytics dashboard using tools like Spotfire/Tableau.
• Functions as Subject Matter Expert (SME) and Lead on multiple projects.
• Assist in the development and implementation of solutions to global technical service issues and concerns regarding EDC or SAS or other proprietary software, including proactive prevention strategies.
• Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies.
• Plan, manage, execute, and oversee all SDTM programming activities across multiple studies.
• Co-ordinate activities of all SDTM programmers across projects and provide technical/functional expertise and makes statistical programming decisions/recommendations at study or project level.
• Develop/validate Custom/Complex Edit-Check programs, reports, SDTM domains and efficiently handle external data and data reconciliations.
• Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
• Perform Lead/Code review to ensure quality deliverables to clients.
• With assistance meet with Data Manager on assigned projects to discuss technical strategies, contractual obligations, and timelines. Provide information on resource needs as appropriate.
• Provide consultation in the area of database design and development with Data Managers.
• Participate in the ongoing review of the processes used to ensure adaptation of best practices.
• Provide expert technical guidance to project teams, external and internal clients within a global setting. Assist in developing and maintaining data loading procedures.
• Maintain awareness of new developments in EDC products / Standards / tools which may be applied to improve the efficient use of these systems.
• Take initiative to accept new challenges in programming. As a SME be initial point of contact for programming for a project and assist Interns and Programmers Analysts in complex issue troubleshooting, documentation and adhering to Standards.
• Follow attention to detail approach and participate in sponsor meetings and audits/inspections.
• Mentor and aide in staff development and achievement of competency standards, regulations pertaining to computerized systems to projects to ensure compliance.
• Oversees the project work of technical and design staff. Manage projects within the scope of assigned budgets.
• Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
• Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities provide support, troubleshooting of EDC, and act as the study team liaison.
• Prepare and provide internal training on advanced topics as needed in conjunction with Senior Management.
• Conducts team meetings, provides technical guidance/assistance to Programmers, and perform other duties as assigned by Manager.
• Participates/Assists in the Business Development presentations and bid development.
• And all other duties as needed or assigned

Qualifications (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
• Fluent in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 6 to 9 years of relevant work experience to include data management and/or database programming activities including three years Medidata Rave, Oracle InForm, or equivalent experience or SAS Programming or Spotfire or Tableau experience.
• Demonstrate excellent problem-solving skills, a proactive approach, and the ability to make sound decisions.
• Demonstrated skill in leading teams, by example and mentoring staff.
• Excellent oral and written communication and presentation skills.
• Knowledge of clinical trial process and data management, CRF design, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
• Demonstrated ability to work in a team environment.
• Demonstrated ability to handle multiple competing priorities.
• Proven managerial and interpersonal skills.

Physical Demands/Work Environment:

• Office work environment.

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