Program Manager Clinical Research

Montefiore Health System; East Street; On-site; GBP 58,000 - 74,000; Full time

Job summary

A leading healthcare organization seeks a Clinical Research Program Manager to oversee compliance and quality assurance for clinical trials. The role involves conducting detailed patient and pharmacy reviews, ensuring adherence to regulatory standards, and serving as the Administrator for the Data and Safety Monitoring Committee. Candidates should possess a Bachelor's degree and significant experience in clinical research, coupled with strong analytical and leadership skills.

Qualifications

• 5 years of work experience required; minimum of 3 years of experience in clinical research.
• Strong working knowledge of ongoing monitoring techniques and quality management principles.
• Ability to manage projects and work with minimal supervision.

Responsibilities

• Monitor compliance and quality assurance for cancer clinical trials.
• Conduct patient case and pharmacy reviews for trials.
• Serve as Administrator for the Data and Safety Monitoring Committee.

Skills

Analytical skills

Project management

Communication skills

Leadership

Education

Bachelor's degree

Master's degree

Tools

GCP (Good Clinical Practice)

Job description

Overview

City/State: Bronx, New York

Grant Funded: Yes

Department: Cancer Clinical Trials Office

Work Shift: Day

Work Days: MON-FRI

Scheduled Hours: 9 AM-5:30 PM

Scheduled Daily Hours: 7.5 HOURS

Pay Range: $80,000.00-$100,000.00

The Clinical Research Program Manager- Monitor, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office. The Clinical Research Program Manager- Monitor will be responsible for all ongoing monitoring activities - patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder). The CRM will provide routine reviews and determine if there are compliance concerns that warrant a formal [of] the trials. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.

The Clinical Research Program Manager- Monitor will work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).

The Clinical Research Program Manager- Monitor will serve as the Administrator for the MECC Data and Safety Monitoring Committee.

In addition, the Clinical Research Program Manager- Monitor will work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

Responsibilities

• Monitor, under supervision, compliance and quality assurance for Montefiore Einstein Cancer Clinical Trials Office.
• Conduct patient case reviews, pharmacy reviews, and regulatory reviews for Investigator Initiated Trials.
• Perform routine reviews and identify compliance concerns warranting formal action.
• Adhere to Good Clinical Practice (GCP), SOPs, DSMP, and applicable regulatory requirements.
• Provide feedback on findings and evaluate CAPA implementations.
• Serve as Administrator for the MECC Data and Safety Monitoring Committee.
• Develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

Qualifications

• Bachelor's degree required; Master’s degree preferred.
• 5 years of work experience required; minimum of 3 years of experience in clinical research.
• CCRP/CCRC Certification preferred.
• Prior experience with internal audits and/or FDA inspection preparations.
• Demonstrated knowledge of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards related to clinical research.
• Strong working knowledge of ongoing monitoring techniques (including criteria development and trending).
• Strong working knowledge of quality management principles, tools, and risk management techniques.
• Analytical and critical thinking skills to recognize trends.
• Ability to manage projects: prioritize, identify barriers, and meet deadlines.
• Ability to prioritize, organize, plan, and implement services while handling multiple projects/problems simultaneously.
• Demonstrated communication, leadership, and team-building skills, including effective problem solving and motivating others.
• Demonstrated ability to work with minimal supervision.
• Effective written and verbal communication.

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.