Principal Data Programmer: Rave/ Veeva (Remote)
Job Description:
Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design.
Assist in the development and implementation of solutions to global technical service issues/ concerns regarding Medidata Rave or Veeva or SAS or Other proprietary software including proactive prevention strategies.
Provide support to Data Management for time/cost estimates, prepare and present to potential clients on global technical support capabilities.
Meet with Data Manager on assigned projects to discuss technical strategies, contractual obligations, and timelines. Escalate resource needs as appropriate.
Provide leadership and consultation in the area of database design and development with Data Managers.
Complete assigned work utilizing Medidata Rave or Veeva or SAS or other proprietary software according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.
Author code to scientifically map the data attributes using SAS programs and author specifications/applications designed to analyze and report complex clinical trial data of various therapeutics mainly oncology, respiratory, cardiovascular, neurology, dermatology, the infectious disease for electronic review, exchange, transformation, and submission of data in CDISC SDTM format.
Serve as Lead Statistical Programmer including leading oversight of partnership programs.
Plan, manage, execute, and oversee all programming activities across multiple studies including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Develop and /or Perform Lead review of SAS datasets, Define XML/PDFs, aCRFs, Reviewers Guide and ensure Quality of deliverables, to support Standards.
Mentor and aide in staff development, achievement of competency standards, development of global technical services competency models.
Participate in the development of global, harmonized SOPs, specific quality work instruction for technical service group activities and ongoing review of the process used by the Technical Services Group to ensure adaptation of best practices.
Provide input into assessments of resource requirements on a regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project. Assist management with evaluation of new technologies as assigned.
Participate in the evaluation and validation of new or updates to EDC software. Conduct Peer Review/Quality Control of study design for assigned projects.
Provide expert technical guidance to project teams, external and internal clients within a global setting, provide internal training on advanced topics as needed in conjunction with Senior Management.
Advise management of changes in scope of projects to enable the timely development of change orders and provide feedback on the development potential of staff to assist in staff development.
Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems and regulations pertaining to computerized systems to projects to ensure compliance.
Pro-actively market and sell the services of Clinical Solutions including sales presentations and bid defense meetings.
Assist Sponsors with Technology adoption and implementation tasks including Vendor Selection, Investigator site selection, and site training as required.
Maintain technical competency through participation in internal and external professional seminars and participation in professional organizations.
Minimum Required:
10+ years of relevant Programming experience to include data management and/or database programming activities including three years Medidata Rave, Veeva, or equivalent 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, SAS programming 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.
Education/Qualifications/Certifications and Licenses:
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.
US Pay Range: $110,000 - $145,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www. fortrea. com.
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