The DCT Lead, Clinical Trial Configuration will work within a sponsor-dedicated model, partnering closely with sponsor stakeholders and cross-functional clinical study teams to support the implementation, delivery, and oversight of clinical technologies used across clinical trials.
This role serves as a Clinical Technology Subject Matter Expert (SME) within assigned clinical study teams and supports the system delivery lifecycle in collaboration with Clinical Operations, technology, quality, vendors, and other relevant stakeholders. The role provides study-level leadership and coordination for the implementation of clinical technologies such as eCOA, eConsent, telehealth solutions, medical devices, COA instruments, and other clinical trial technologies.
The DCT Lead will support technology implementation and deployment, vendor coordination, issue resolution and escalation, documentation and inspection readiness, and the adoption of clinical technology standards, processes, and governance models.
Summary of Responsibilities:
- Serve as the Clinical Technology SME within assigned clinical study teams, supporting the implementation and oversight of clinical trial technologies.
- Act as a primary point of contact for the implementation of clinical technologies such as eCOA, eConsent, telehealth solutions, medical devices, COA instruments, and other clinical trial technology solutions.
- Support the system delivery lifecycle in collaboration with Clinical Operations, technology, quality, vendors, and other applicable stakeholders.
- Coordinate study-level clinical technology activities and support delivery against established milestones, deliverables, and quality expectations.
- Collaborate with clinical technology vendors to support study implementation activities and facilitate timely resolution of issues.
- Perform study-level work prioritization, issue resolution, vendor coordination, and escalation, as appropriate.
- Support implementation and adoption of new clinical technology capabilities, business processes, technology standards, and governance models.
- Follow established strategies for study-level technology implementation and deployment and support applicable vendor oversight activities.
- Identify and troubleshoot technology-related issues impacting clinical trial delivery and collaborate with appropriate stakeholders to facilitate resolution or escalation.
- Apply System Development Life Cycle (SDLC) principles to clinical technology implementation and related activities.
- Support applicable documentation requirements throughout the technology delivery lifecycle, including validation and testing activities as appropriate.
- Confirm applicable Clinical Technology Trial Master File documentation supports archival and inspection readiness.
- Support submission readiness activities and regulatory or client audits/inspections involving Clinical Trial Configuration activities.
- Maintain working knowledge of applicable SOPs, GxP requirements, FDA and ICH regulations, industry standards, quality control principles, and ALCOA++ data integrity principles.
- Support relevant metrics and reporting associated with clinical technology activities.
- Work independently and effectively manage multiple studies, activities, priorities, and stakeholders within a global, cross-functional environment.
- Provide guidance and knowledge sharing regarding clinical technology processes and responsibilities.
- Participate in process improvement initiatives, SOP reviews, special projects, and other activities as assigned.
Qualifications (Minimum Required):
- Bachelor's degree in Life Sciences, Health Sciences, Information Technology, Computer Science, or a related discipline, or equivalent relevant experience.
- Strong communication and interpersonal skills with the ability to collaborate effectively across global and cross-functional teams.
- Fluent in English, both written and verbal.
Experience (Minimum Required):
- Minimum of 6 years of relevant experience within clinical research/drug development, including direct clinical technology experience.
- Experience supporting the implementation, integration, deployment, or oversight of clinical trial technologies.
- Project management skills and experience supporting implementation of clinical technologies such as eCOA, eConsent, telehealth, medical devices, COA solutions, clinical data technologies, or related integrations.
- Experience applying System Development Life Cycle (SDLC) principles within a regulated environment.
- Working knowledge and understanding of FDA and ICH regulations, industry standards, and quality control principles.
- Understanding of ALCOA++ principles and their application within regulated clinical technology environments.
- Experience working across different phases of clinical drug development.
- Strong project management, organizational, and prioritization skills.
- Strong analytical and problem-solving skills with a proactive approach to identifying and resolving issues.
- Ability to manage multiple activities, stakeholders, deliverables, and timelines simultaneously.
- Ability to work independently, take initiative, and adapt to evolving technologies, processes, and business needs.
- Strong attention to detail and commitment to quality.
Preferred Qualifications Include:
- Experience working within a sponsor-dedicated or Functional Service Provider (FSP) model.
- Experience supporting clinical technology implementation across multiple clinical studies or development programs.
- Experience working directly with clinical technology vendors and cross-functional sponsor stakeholders.
- Experience supporting regulatory inspections or audits involving clinical technologies, systems, or associated documentation.
- Experience with clinical technology validation and testing activities.
Physical Demands/Work Environment:
- Professional office and/or remote work environment, as applicable.
- Ability to collaborate effectively within global, virtual, and cross-functional teams.
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