Offer summary

Qualifications:

Bachelor’s degree in Life Sciences, Computer Science, Engineering, Business, or related field., At least 8 years of experience as a Clinical Programmer or Study Designer supporting global clinical trials., Strong proficiency in Medidata Rave and experience with clinical systems like CTMS, EDC, IVRS, or ePRO., Excellent communication skills and ability to work independently in a fast-paced environment..

Key responsabilities:

Accountable for quality delivery and ensuring team competencies within the service area.

Lead study-level system requirements meetings with vendors and internal stakeholders.

Collaborate with Data Management to define data transfer requirements and manage project timelines.

Identify, track, and resolve study-related technical issues while contributing to process improvement initiatives.

Job description

100% Remote, preferably Pacific Time (but Eastern is acceptable)
Duration: 1 year contract, extendable by 6 months

The ideal candidate will have at least 8 years of experience as a Clinical Programmer or Study Designer supporting global clinical trials, with strong proficiency in Medidata Rave for study design, edit check programming, and metadata configuration. They should possess a Bachelor’s degree or higher and have worked in collaboration with Functional Service Providers (FSPs), preferably IQVIA, acting as a liaison between data management teams and offshore programming teams. The candidate must be technically skilled, able to interpret and translate study requirements from Protocol Leads (PLs) and Lead Data Managers (LDMs), and ensure quality and timely delivery of database builds and updates. Experience in big pharma environments (e.g., Pharmaceutical, Gilead) and exposure to Veeva EDC or automation tools is a plus. The role is fully remote, with a preference for candidates in the Pacific Time Zone. Strong communication skills, a collaborative mindset, and the ability to work independently in a fast-paced setting are essential. Overqualified candidates or those lacking clinical EDC experience will not be considered. see red flags.

Summary of Key Responsibilities
Accountable for quality delivery and ensuring team competencies within the service area

Lead study-level system requirements meetings with vendors and internal stakeholders

Assist in designing and developing study-specific technical documentation

Support internal teams in managing project timelines and associated activities

Collaborate with Data Management (DM) to define data transfer requirements

Work with external partners to manage user acceptance test (UAT) creation and execution

Identify, track, and resolve study-related technical issues

Contribute to continuous process and quality improvement initiatives

Preferred Qualifications
Bachelor’s degree in Life Sciences, Computer Science, Engineering, Business, or related field

4+ years of experience in clinical development

Hands-on experience with clinical systems such as CTMS, EDC, IVRS, ePRO, or similar technologies in the pharmaceutical/biotechnology industry

Strong knowledge of Good Clinical Practices (GCP) and relevant FDA regulations

Demonstrated project management and technical expertise

High attention to detail with strong documentation and communication skills

PMP certification (preferred)

Prior vendor management experience

Excellent time management and organizational abilities

Strong problem-solving, judgment, and decision-making skills

Ability to thrive in a team-based environment with minimal supervision