Site: The Brigham and Women's Hospital, Inc.

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

Job Summary

Clinical Research Project Manager with monitoring experience

Responsible for the management of multiple clinical research studies. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time. Responsibilities also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities, oversee budget management and subcontracts with associated institutions.

The Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums. The goal is to maximize effective utilization of personnel and resources, while maintaining high levels of quality. The position will be responsible for conducting clinical trial monitoring activities to ensure participant safety, data integrity, protocol compliance, and adherence to applicable regulatory requirements and Good Clinical Practice (GCP) standards. Responsibilities include supporting site initiation, conducting interim monitoring visits, identifying and resolving compliance and data quality issues, and completing site close-out activities to ensure high-quality clinical trial conduct.

 

. Study Document Development and Management

• Prepare study protocols and informed consent forms.
• Develop recruitment materials.
• Develop manuals of procedures.
• Prepare site and staff training materials.
• Provide and manage a study portal for access to study documents and trial materials.

2. Regulatory Management

• Develop and manage the Investigator’s Brochure, as applicable.
• Prepare and submit Investigational New Drug (IND) applications and amendments, as applicable.
• Prepare and submit IND expedited safety reports, as applicable.
• Prepare and submit IND annual progress and safety reports, as applicable.
• Submit Institutional Review Board (IRB) applications and required reports.
• Manage site regulatory documents and the Trial Master File (TMF).
• Manage ClinicalTrials.gov postings.
• Notify the FDA of study closure, as applicable.

3. Investigational Product Management

• Purchase and procure investigational products (IP) and placebos.
• Develop investigational product labels.
• Label and distribute investigational products.
• Maintain investigational product records and reporting.
• Develop pharmacy manuals.

4. Data Management and Biostatistics

• Develop case report forms (CRFs).
• Build and manage clinical databases.
• Develop the Clinical Data Management Plan, including randomization implementation.
• Develop and provide study conduct reports.
• Collaborate with biostatistics to build and manage the randomization system.
• Collaborate with biostatistics to develop the Statistical Analysis Plan.
• Collaborate with biostatistics to conduct data analysis.

5. Safety Oversight and Clinical Trial Monitoring

• Administer oversight committees, such as the Data Safety Monitoring Board (DSMB).
• Develop pharmacovigilance and safety monitoring plans.
• Review safety data.
• Report serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to the IRB and sponsor, as applicable.
• Develop site initiation and monitoring plans.
• Conduct site initiation visits.
• Conduct interim monitoring visits.
• Conduct site close-out visits.

6. Site Activation, Training, and Trial Conduct

• Conduct site feasibility assessments.
• Approve site activation.
• Provide site training and initiation.
• Oversee participant recruitment and informed consent processes.
• Oversee research procedures involving study participants.
• Ensure appropriate recording of adverse events (AEs), SAEs, and SUSARs.
• Investigate and remediate site noncompliance.

7. Study Closure, Reporting, and Analysis

• Oversee site closure and required reporting.
• Coordinate the return or destruction of unused investigational products.
• Notify the IRB of study closure.
• Prepare and submit final study reports.
• Oversee the archiving of site records, including the site Trial Master File.
• Coordinate publication of trial findings.
• Collaborate with biostatistics on final data analysis.

Quality and Process Improvement

• Oversee the development, implementation, and administration of quality assurance processes.
• Continuously develop metrics and tools to monitor, trend, and report performance measures.
• Facilitate and/or participate in communications with internal and external stakeholders regarding training, performance measures, and quality assurance.

Education and Qualifications

Education

• Bachelor's degree in a related field required.
• Master's degree in a related field preferred.
• Experience in lieu of a degree: Not accepted.

Experience

• 5–7 years of research-related experience required.
• 1–2 years of supervisory experience preferred.
• Clinical trial monitoring experience preferred.

Knowledge, Skills, and Abilities

• Ability to make independent and effective decisions.
• Strong organizational and communication skills.
• Ability to effectively supervise and train staff.
• Strong database management and computer skills.
• Demonstrated analytical and problem-solving skills.
• Strong budget management skills.

 

 

Hybrid

 

221 Longwood Avenue

 

40

 

Regular

 

Day (United States of America)

 

Pay Range

$63,252.80 - $102,596.00/Annual

 

Grade

7

 

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

 

2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

 

Mass General Brigham Competency Framework