POSITION OVERVIEWThe Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture requirements, bridging the gap between protocol requirements and implementation. This role oversees the comprehensive lifecycle of the eSource platform, from initial design and specification to final build and implementation. A critical component of this position is the oversight of offshore build teams, ensuring all design and build requirements remain on track and meet the highest standards of quality and efficiency.
DUTIES AND RESPONSIBILITIESDuties include but are not limited to:
- Define and specify eSource design requirements for assigned studies, collaborating closely with internal teams and clients to ensure protocol alignment.
- Work with offshore teams to ensure all platform design and build milestones are met according to project timelines and technical specifications.
- Serve as the SME for system capabilities, data capture configuration, and the validation of the eSource Platform.
- Drive efficiency by implementing standard templates and libraries and contributing to the development of streamlined building and QC
- Collaborate in highly cross-functional project teams, interacting with Clients, Site Operations Managers, and internal staff to document data collection requirements.
- Create and maintain project timelines, monitoring progress of all design activities while remaining accountable for quality metrics, KPIs, and performance benchmarks.
- Lead the build, testing, and implementation of direct data capture services, ensuring system integration and user acceptance testing to meet quality deliverables.
- Participate in the review and revision of SOPs and work instructions.
- Train and mentor Platform Build Managers and support specialists to foster a culture of excellence and operational speed.
- Oversee and perform user access management for all Science 37 eSource platforms.
- Partner with Clinical Operations and Data Management to provide early strategic input on protocol design and execute post-production changes.
- Build and maintain effective working relationships with clients, sponsors, and vendors to ensure project success.
QUALIFICATIONS & SKILLSQualifications The following qualifications are preferred and/or equivalent applicable experience:- Required: 3+ years of experience in clinical research or life science industry, including at least 3 years in design of CRF/ePRO or other clinical trials database capture software.
- Required: 2+ years of CRIO platform experience is required.
- Bachelor's degree or equivalent experience in the health science field.
- Extensive knowledge of the clinical research development process
- Experience in a fast-moving, growth-minded company, and are comfortable with needing to be flexible and adaptable as requirements change.
Skills/Competencies- Understanding of drug development process and regulatory guidelines.
- Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities
- Ability to create and review protocols, programs, and assess the success of a project.
- Experience in building and guiding organizational teams, leveraging each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities
- Proactive problem-solving abilities and follow through
- Successful situational responsive decision-making
- Strong communication and presentation skills - both written and verbal
- Ability to articulate ideas to both technical and non-technical audiences
- Ability to establish and maintain positive sponsor, project team member, vendor and internal Science37 relationships
- Have excellent time management skills, action-oriented, goal-oriented, and innovative 11. Demonstrates high level of attention to detail, outstanding organizational activities and good blend of analytical skills, strategic thinking, planning and implementation
- Working knowledge of Microsoft Office suite, Google applications, and electronic clinical technologies.
- Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
REPORTINGThe reporting leader will assign projects, provide general direction and guidance. The incumbent is expected to perform duties and responsibilities with minimal supervision.
