The GlomCon Foundation is a mission-driven nonprofit charitable 501(c)(3) organization. Our mission is to provide medical education based on the best available evidence, free of commercial and ideological bias, and to create a platform for research collaborations among clinicians and academics guided by patients’ and caregivers’ needs.
We seek an experienced clinical research study manager to manage several global real-world evidence studies' start-ups and daily operations. The clinical research study manager will provide clinical and administrative expertise to support GlomCon Foundation and participating research sites. The clinical research study manager will be accountable for project management activities, oversight of multiple vendors/sites, and for conducting a global clinical study in compliance with applicable clinical and regulatory requirements/standards and in alignment with the business needs. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and is critical to the success of the business.
In this position, the clinical research study manager will collaborate with GlomCon leadership/administrators, funders, site investigators, and staff in both administrative and research capacities. This opportunity involves administrative, leadership, and research skills and thus will be most suited to applicants who have had prior experience conducting human research, RWE, and registry research.
Essential Functions:
● Serves as the primary point of contact for stakeholders and research sites and addresses all research activities/issues.
● Prepares sponsor-level IRB submissions and reports, and maintains regulatory documents in compliance with SOPs and GCP procedures.
● Aids and guides to sites in obtaining IRB/local approvals.
● General project management includes scheduling study sessions, meetings, phone calls, etc., developing tracking tools, and performing other clinical activities as needed during clinical study conduct.
● Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
● Monitors and tracks clinical study progress and provides status update reports.
● Manages the study budget, payment process, and invoice reconciliation for all clinical study vendors, including investigative sites.
● Oversee the work and performance of clinical team members, including coaching and supporting any direct reports.
● Build and maintain strong relationships with investigators/site staff/personnel to support recruitment/retention.
● Conducts or oversees site visits as required to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.
● Monitor/assess study progress, identify risks, and implement corrective measures to achieve study goals and maintain timelines.
● Ensure regulatory compliance with FDA guidelines, ICH-GCP standards, and other relevant regulations.
● Lead study start-up activities, collaborating with Clinical Operations teams for site selection, feasibility assessments, and documentation.
● Develop and execute operational strategies for the management of RWE studies.
● Support site initiation, training, and monitoring to guarantee compliance with protocols, regulatory standards, and ICH-GP guidelines.
● Collaborate with cross-functional teams, including data management, clinical scientists, regulatory groups, and investigators, to uphold operational excellence.
● Maintains detailed study files, including study master file and site file oversight, and conducts regular reviews.
● Other duties as assigned.
Qualifications:
● Bachelor’s Degree in a scientific field of study, although we may consider other degree emphases or experiences.
● At least 10 years’ experience directly supporting and overseeing all aspects of global clinical study/research/trial management, ensuring high-quality study data is delivered on time and within budget.
● Previous experience directly managing others or equivalent experience.
● In-depth, broad, and working knowledge of clinical research regulations, guidelines, and best practices, including ICH-GCP, FDA/EMA, ISO, and other applicable regulations, CECs/DSMBs.
● Demonstrated experience in managing and executing clinical studies from start-up to close-out, overseeing the work and performance of clinical team members, including coaching and supporting any direct reports.
● Responsible for authoring internal documents, clinical study reports, or clinical evaluation reports.
● Strong understanding of therapeutic areas, including familiarity with treatment modalities, disease diagnosis/progression, and related medical terminology (nephrology preferred).
● Proficiency and experience with Microsoft Word, PowerPoint, and Windows; EDC/Data Management Systems.
● Ability to manage multiple project teams and sites and to work in a fast-paced environment while managing multiple priorities.
● Operate as a team and/or independently while demonstrating flexibility to changing requirements.
● Must have excellent verbal and written communication skills and the ability to predict and prevent problems before they arise.
● High attention to detail and accuracy.
Job Type: Full-time
Work Location: Remote
