Clinical Systems Manager
Overview
Social & Scientific Systems (SSS), a DLH Company, works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.
The role of the Clinical Systems Manager is to facilitate the identification, documentation, validation, implementation, operation, and maintenance of all systems utilized for clinical research across the portfolio of clinical programs within the Clinical Trials Research Services Practice Area in SSS.
Responsibilities
Develops clinical system work plan schedules, milestones, cost estimates and budgets; identifies areas of risk and incorporates risk mitigation plan; develops timelines and schedules of deliverables and manages resources to achieve specified deliverables and milestones for each system specified within the clinical system software suite.
Serves as subject matter expert for regulatory requirements surrounding the documentation, validation, and a working knowledge of SSS’ intended use of the clinical systems suite.
Oversee, mentor, hire, and train 5-10 clinical systems staff.
Establishes annual maintenance plans, functional release schedules, system updates, and security patches for all clinical systems.
Serves as primary point of contact and company representative with system or software vendors; communicates and negotiates effectively with the vendor on all purchases; including, but not limited to, product purchases, systems support contracts, maintenance arrangements, and license agreements.
Creates and maintains a repository of system-specific summaries and write-ups for proposal documentation and other business development documentation, as necessary.
Supports business development and proposal efforts relating to cost/budget estimates for opportunities utilizing clinical system resources, as necessary.
Updates system pricing and forecasting, and/or renegotiates unit pricing and usage expectations with systems or software vendors, as necessary.
Engages with other functions and internal/external business partners as required; Leads the development of comprehensive processes that ensure quality and completeness of the clinical systems solution.
Communicates with functional area leads and other key stakeholders to ensure project-specific needs are being effectively met with the clinical system or software deployed.
Communicates with Information Technology Services (ITS) leads to ensure appropriate system-specific disaster recovery, back-ups, and maintenance procedures are in place, utilized, and exercised at pre-determined intervals for self-hosted clinical systems and data.
Represents SSS in all clinical systems audits.
Creates system-specific training materials, courses, curriculums, and content to ensure the effective training for both internal and external system users.
Lead and prioritize multiple projects simultaneously as a part of vendor management.
Supports the creation of standard operating procedures (SOPs) and system-specific documentation with the Quality Management Office.
Performs additional duties as required.
Qualifications
Bachelor’s Degree with at least 10 + years of relevant experience in support of clinical trial operations is required.
At least 3 years of experience with staff management
Must have a technical understanding of key clinical systems, including, but not limited to, Medidata Rave, Veeva Vault eTMF, Open Clinica and Oracle Clinical, and the ability to translate that understanding into day-to-day operations, training presentations, and system/process documentation.
A solid understanding of GCP and FDA Code of Federal Regulation is required.
Requires proficiency with systems development, architecture frameworks, integration pathways, and implementation.
Experience handling international projects or a geographically dispersed development tea, preferred.
The ability to partner and influence people at all levels of the organization is required.
The individual must be self-motivated with a track record of demonstrated leadership abilities with both direct reports and in a matrix organization.
Must have problem-solving and decision-making skills along combined with strong planning, organizational, and project management skills.
This position may require up to 20% domestic and international travel.
DLH is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.