Job Description

Position Summary
Responsible for the operational oversight of the clinical research programs across assigned disease areas. This role is responsible for portfolio management, program growth, and cross-functional coordination to ensure studies are feasible, efficiently executed, and align with programmatic priorities.

Job Responsibilities
Serve as the central point person for disease program-level related matters . Foster effective collaborations across operations, finance, contracts, regulatory, and ancillary teams to ensure seamless program execution and compliance.
Provide operational guidance to multiple multi-disciplinary clinical research programs. Monitor program performance, identify risks, and implement solutions to maintain timelines, enrollment targets, and overall study status.
Oversee the initiation, conduct, and closeout across the portfolio, ensuring consistency and efficiency.
Evaluate operational feasibility of new studies, including capacity, and resource requirement. Guide prioritization and activation strategies to optimize timelines and performance.
Assist disease leaders and administrative leadership with bolstering growth and development of clinical research within assigned services.
Support the conceptualization and launch of new initiatives, including research, educational, and translational programs.
Facilitate cross-departmental and interdepartmental collaborations to enhance research capabilities and program reach.
Support investigators with development and execution of investigator-initiated studies, including background research, writing or editing paper or presentation drafts, and writing or editing grant submission drafts.
Allocate resources based on portfolio complexity, patient volume, program priority. Provide high-level guidance on workload distribution and staffing models for assigned programs.
Ensure program-level compliance with regulatory requirements, SOPs, and institutional policies.
Oversee audit and inspection readiness, review findings, direct the development and execution of CAPAs. Serve as a liaison during external audits and inspections.
Oversee reconciliation of study level financial activity, including reconciliation of payments, invoiceable and financial tracking.
Contribute to the development of SOPS and best practices across programs. Identify opportunities for process improvement and operation efficiency at the program level.
Perform other responsibilities as assigned to support departmental, institutional objectives.
Education
Bachelor's Degree in related field
Experience
Advanced degree may be considered in lieu of experience
6+ years of experience in clinical research setting with exposure to a team research environment at all levels
2+ prior management/supervisory experience required
Experience with regulatory, data management, and billing compliance aspects of clinical research.
Experience with conducting and carrying out protocols and research coordination.
Knowledge, Skills and Abilities
Strong knowledge in Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
Excellent written and verbal communication skills.
Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
Demonstrated proficiency with MS Office Suite and database applications.
Demonstrated organizational skills and ability to pay close attention to detail.
Demonstrated critical thinking and analytical skills.
Demonstrated ability to multi-task and prioritize in a fast-paced environment.
Demonstrated ability to remain focused despite frequent interruptions.
Ability to treat confidential information with utmost discretion.
Ability to exercise standards of professionalism, including appearance, presentation, and demeanor.
Demonstrated ability to work effectively in a collaborative manner with all depart mental faculty and staff, as well as other institutional representatives.
Ability to work independently.