Manager, Clinical Research - Hybrid as needed

Job Description

We are seeking a highly collaborative and experienced research manager to administratively lead a growing portfolio of federal, industry, and philanthropically funded aging research. This role requires a strong understanding of scientific principles, regulatory requirements, project management methodologies, and excellent interpersonal skills to navigate the complexities of large, externally funded research endeavors in traditional, hybrid, and fully decentralized environments. The Manager, Clinical Research will lead a team of research support staff that focuses on recruitment and enrollment of research volunteers, oversees data collection efforts, and contributes to the successful execution of active research projects.

Job Responsibility

1. Funded Research Operational Leadership:
   1. Leads the operations of current and future funded research projects from study start up through closeout, translating the Principal Investigators’ scientific vision to actionable research plans.
   2. Develops, implements, and monitors comprehensive project plans, timelines, and milestones across all funded projects.
   3. Develops standardized operating procedures (SOPs) and Manual of Operations (MOPs) for all study activities.
   4. Ensures timely and efficient participant recruitment, screening, enrollment, and retention. 
   5. Leads cross-functional meetings to support the aims of research projects.
   6. Manages study drug/device accountability, ensuring proper storage, dispensing, and return/destruction, as applicable.
   7. Coordinates the collection, processing, and shipping of biological samples, as required.
   8. Proactively identifies and addresses operational challenges, risks, and bottlenecks, escalating critical issues to the PIs as needed.
   9. Fosters a collaborative and high-performing team environment. 
   10. Serves as the administrative contact for appointed Safety Officers and Data and Safety Monitoring Boards.
   11. Represents research needs and interests in meetings with Northwell Health and Feinstein Institutes for Medical Research stakeholders.
2. Team Management:
   1. Directly supervises, mentors, and evaluates clinical research staff working on funded research projects.
   2. Oversees the recruitment, hiring, onboarding, and performance management of direct reports.
   3. Provides administrative oversight and problem resolution guidance.
   4. Ensures all staff are adequately trained on study protocols, Standard Operating Procedures, Manual of Operations, Good Clinical Practice, and regulatory requirements.
   5. Actively pursues and shares knowledge about policies, regulations, and procedures.
   6. Fosters a collaborative environment that emphasizes Good Clinical Practice and excellence in research to meet aggressive enrollment goals. 
   7. Manages conflict resolution and facilitates decision-making within the study team.
3. Grant and Regulatory Compliance: 
   1. Ensures strict adherence to sponsor terms and conditions, federal regulations, institutional policies, and ICH-GCP guidelines. 
   2. Manages all IRB submissions, modifications, continuing reviews, and adverse event reporting. 
   3. Oversees the maintenance of complete, accurate, and up-to-date regulatory binder documents.
   4. Prepares sponsor progress reports in collaboration with the PIs. 
   5. Manages interactions and reporting to the Data and Safety Monitoring Board or Safety Officer, as applicable.
4. Budget Management:
   1. Works closely with the Research Intelligence Financial Operations team to monitor and manage grant budgets, tracking staff effort, study expenditures, forecasting future needs, and ensuring compliance with institutional and sponsor financial guidelines.
   2. Oversees and manages sub-awards to collaborating institutions, including assisting with budget review, invoicing, and performance monitoring. 
   3. Ensures efficient allocation and utilization of personnel, equipment, and other resources.
   4. Assists with the development of budget proposals to support future grant submissions, leveraging institutional knowledge and prior experience to effectively estimate total study costs.  
5. Data Management and Quality Assurance:
   1. Collaborates with study Investigators on the design and implementation of data collection tools. 
   2. Oversees data entry validation, query generation/resolution, and quality control processes to ensure data integrity and accuracy. 
   3. Implements and manages quality assurance procedures, including regular internal audits. 
   4. Ensures proper documentation and source data verification processes are in place. 
6. Communication & Stakeholder Relations:
   1. Facilitates regular and effective communication between the PIs, study team members, and other internal stakeholders. 
   2. Serves as the primary point of contact for daily study operations. 
   3. Presents progress updates and key performance indicators to internal and external groups. 

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 6-8 years of relevant experience and 2-5 years of leadership / management experience, required.

HIGHLY PREFFERED

• Certified Clinical Research Coordinator encouraged.
• Experience managing federally funded clinical trials required. 
• In-depth knowledge of Good Clinical Practice.
• Strong written and oral communication skills.
• Strong attention to detail and ability to follow projects through to completion.
• Demonstrated ability to manage multiple competing priorities and deadlines.

*Additional Salary Detail 
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).