Senior Principal Data Programmer (Remote)

Senior Principal Data Programmer (Remote)

Job Description:

• Provide programming/study start-up management or other support and assist CDM managers in daily technical operations
• Respond to and solve technical oriented problems in a timely manner, as appropriate for the position
• Data management experience, with strong protocol interpretation skills, strong system skills from end user perspective and knowledge of site users is needed.
• This individual will support the Lead EDC designer in the database set up making sure the system is technically strong and as well as easy to use for DM and site personnel.
• Plan, manage, execute and oversee all programming activities across multiple studies including but not limited to, resource estimation, working within budget
• 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, CDISC, SAS Programming etc.
• 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
• For Clinical Systems Developers focused on Custom Function development: Application Development experience with C# and .NET
• Programmatically design and model clinical trial data by the study data tabulation model (SDTM) by implementing relevant requirements from regulatory authorities including, FDA, EMA, PMDA, and the pharmaceutical industry standards for product classification such as drugs, biologics, and medical devices
• Author code to scientifically map the data attributes using SAS and SQL 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
• Validate deliverables using industry-preferred software Pinnacle 21, study data technical conformance guidance, and internal SOPs for managing CDISC compliance, clinical data quality, and submission readiness
• 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.
• eAdvise 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
• services of Clinical Solutions including sales presentations and bid defense meetings

Qualifications:

• 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
• 11+ of relevant work 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.

US Pay Range: $105,000 - $140,000 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.

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

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.