EDC Clinical Trial Designer

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

EDC Clinical Trial Designer

The EDC Clinical Trial Designer will create high quality data collection tools for new clinical trials and facilitate activities related to the design, development, documentation, testing and implementation of clinical eCRF databases. Design of eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected. In addition, the EDC Clinical Trial Designer will ensure that all relevant standard operating procedures, Incyte CRF Standards, process and trial-specific guidelines are implemented and utilized to help ensure that a quality work product is produced and timelines and deliverables are consistently met.

Summary of the Essential Functions of the Job

• Proficiency with the following in Central Designer/Studio

• Understanding detailed data collection requirements based on the protocol and input from study team members.

• Working with libraries and creating new forms when suitable forms do not exist.

• Producing annotated study books.

• Basic understanding of workflow design, dynamic forms and events.

• Validation of study design for forms and schedule design.

• Test steps development and QC of forms.

• Basic understanding of activities needed for data integrations, local lab management, coding functionality.

• Input into design of post-production form changes to the live trials.

• Apply lessons learned from one study build to the next

• Ability to conduct meetings with the study team to communicate work scope, project timelines, and project specific requirements.

• Maintain a good working knowledge relative to regulatory requirements, industry trends, benchmarks, and best working practices in data management and database design by reading, participating in relevant training and/or association activities.

Minimum Requirements

• BA/BS degree. Commensurate experience will be considered.
• Minimum of 2 years of Clinical Data Management experience using electronic data capture systems.
• Effective oral and written presentation and communication skills.
• Strong attention to detail and a commitment to high quality work, customer service and getting things right the first time with minimal errors.
• Ability to manage multiple project tasks and deliverables in a fast-paced constantly changing environment.
• Experience in the planning and management of clinical trials in the biopharmaceutical industry or a related field is preferred.
• Familiarity with clinical research processes and CDISC/CDASH/SDTM standards is preferred.

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*