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About the Role
Responsible for the operational oversight of clinical research programs, focusing on portfolio management, program growth, and cross-functional coordination to ensure efficient study execution and alignment with programmatic priorities.
Responsibilities
- Serve as the central point person for disease program-level related matters.
- Foster effective collaborations across operations, finance, contracts, regulatory, and ancillary teams.
- Provide operational guidance to multiple multi-disciplinary clinical research programs.
- Monitor program performance, identify risks, and implement solutions.
- Oversee the initiation, conduct, and closeout across the portfolio.
- Evaluate operational feasibility of new studies, including capacity and resource requirements.
- Guide prioritization and activation strategies to optimize timelines and performance.
- Assist disease leaders and administrative leadership with bolstering growth and development of clinical research.
- Support the conceptualization and launch of new initiatives.
- Facilitate cross-departmental and interdepartmental collaborations.
- Support investigators with development and execution of investigator-initiated studies.
- Allocate resources based on portfolio complexity, patient volume, and program priority.
- Provide high-level guidance on workload distribution and staffing models.
- Ensure program-level compliance with regulatory requirements, SOPs, and institutional policies.
- Oversee audit and inspection readiness, review findings, and direct CAPA development.
- Serve as a liaison during external audits and inspections.
- Oversee reconciliation of study-level financial activity.
- Contribute to the development of SOPS and best practices.
- Identify opportunities for process improvement and operational efficiency.
- Perform other responsibilities as assigned.
Requirements
- 6+ years of experience in a clinical research setting with exposure to a team research environment.
- 2+ years of 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.
Skills
- 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.
- Demonstrated ability to work effectively in a collaborative manner.
- Ability to work independently.
Location
- Upper East Side
Work Type
- Onsite
Experience Level
- Management/Supervisory
Education Level
- Bachelor's Degree in related field
- Advanced degree may be considered in lieu of experience
Salary/Compensations
- $109,200.00 - $125,200.00
About the Company
- Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of “any person, any study.”
Equal Opportunity
- No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
- Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds.
- We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply.
- Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRRA).
- We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.