Job Overview:
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:
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