DCT Lead, Clinical Trial Configuration (Clinical Technology)

Location: Remote, San Jose, Costa Rica

Company

hirify.global provides clinical research and drug development services supported by clinical technologies and cross-functional study teams.

What you will do

• Serve as the clinical technology SME and primary contact for assigned sponsor-dedicated clinical studies.
• Lead study-level implementation, deployment, integration, oversight, and lifecycle delivery for eCOA, eConsent, telehealth, medical devices, COA instruments, and related technologies.
• Coordinate vendors, stakeholders, milestones, deliverables, priorities, issue resolution, escalations, and reporting across multiple studies.
• Support validation, testing, documentation, Trial Master File archival, inspection readiness, regulatory audits, and submission readiness.
• Apply clinical technology standards, governance models, SDLC principles, SOPs, GxP requirements, FDA and ICH regulations, quality controls, and ALCOA++ data integrity principles.
• Provide guidance, knowledge sharing, process improvements, SOP reviews, and support for new technology capabilities and special projects.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, Computer Science, or a related discipline, or equivalent relevant experience.
• Minimum 6 years of relevant clinical research or drug development experience, including direct clinical technology experience.
• Experience implementing, integrating, deploying, or overseeing clinical trial technologies and supporting technologies such as eCOA, eConsent, telehealth, medical devices, COA solutions, clinical data technologies, or related integrations.
• Project management, organizational, prioritization, analytical, problem-solving, communication, and interpersonal skills.
• Experience applying SDLC principles in a regulated environment and knowledge of FDA and ICH regulations, industry standards, and quality control principles.
• Understanding of ALCOA++ principles in regulated clinical technology environments.
• Experience across different phases of clinical drug development and the ability to manage multiple activities, stakeholders, deliverables, and timelines.
• Ability to work independently, take initiative, adapt to evolving technologies and processes, and maintain strong attention to detail and quality.
• Fluent English, written and verbal, is required.

Nice to have

• Experience in a sponsor-dedicated or Functional Service Provider model.
• Experience supporting clinical technology implementation across multiple studies or development programs.
• Experience working directly with clinical technology vendors and sponsor stakeholders.
• Experience supporting regulatory inspections or audits involving clinical technologies, systems, or documentation.
• Experience with clinical technology validation and testing activities.

Culture & Benefits

• Full-time position in a professional office and/or remote work environment.
• Collaboration takes place across global, virtual, and cross-functional teams.
• Requires independent work and effective management of multiple studies, priorities, stakeholders, and timelines.