Brigham and Women's Hospital
Sr Project Manager BWH TIMI Clinical Research Site
Brigham and Women's Hospital, Boston, Massachusetts, us, 02298
Description
The Sr. Project Manager of the Research Site (PMRS) is responsible for oversight of all operational aspects of the TIMI local MGB/BWH Clinical Research Site. This position reports directly to the TIMI Director of Operations and the TIMI Research Site Physician Director. The(PMRS) works directly with TIMI Physician Investigators to ensure the completion of each of the active studies contracted to participate. The (PMRS) manages multiple clinical trials, which involve human subjects recruited from multiple physician practices and clinical divisions within the MGB Healthcare System. This position includes oversight of all phases of clinical research, including study activation, enrollment, follow up, and closure. The (PMRS) is responsible for strict adherence to the each of the study protocols, meeting expected timelines, and submission of all required data elements as required by each study sponsor.The candidate must possess the ability to work independently in all phases of human clinical research and will routinely interact directly with both out-patients and hospitalized in-patients. The (PMRS) will be required to handle/process human blood, urine, and other biological specimens, as required. S/he must be knowledgeable of U.S. Food and Drug Administration (FDA) Guidelines, the Health Insurance Portability and Accountability Act (HIPAA) Regulations, and Good Clinical Practices (GCP) Guidelines.1. In collaboration with TIMI Principal Investigators (PIs) and study monitors, establishes, maintains and complies with policies and procedures for all assigned clinical trials.2. Is knowledgeable of all aspects of assigned department and trials and is competent to initiate evaluation of questions and/or problems. Assists with triaging issues to appropriate individuals possessing the resources/experience to answer the question or solve the problem.3. Directs all elements involved in the execution of clinical trials, encompassing pre-trial evaluation, trial commencement procedures, participant screening, recruitment, enrollment, appointment scheduling, patient follow-up, case report form completion, adverse event reporting, and study conclusion.4. Coordinate with the MGB Clinical Trial Office (CTO) and Pharmaceutical Sponsors in executing the Confidential Disclosure Agreement (CDA) and Clinical Trial Agreement(CTA), including budget for each clinical trial.5. Plan and conduct regular meetings with clinical trial leadership to engage in strategic planning discussions, explore operational improvement opportunities, and discuss management strategies.6. Possess in-depth knowledge of clinical research operations, project management, budget, contract administration, pharmaceutical sponsor, and institutional guidelines and requirements.7. Manage day-to-day operations, establish and maintain policies and procedures, monitor statistics, manage workflow and output, and coordinate space and infrastructure issues. Ability to engender these skills among staff.8. Lead and manage a team of clinical research professionals, including hiring and training, providing guidance, support, and mentorship as needed.9. Monitor budgets and expenditures, recommending necessary modifications to the principal investigator (PI).10. Develop SOPs, maintain essential documentation, and ensured compliance with current regulations.11. Manage relationships with contract research organizations (CROs), academic institutions, and other external partners to support clinical research initiatives.12. Act as a liaison between the MGB Human Subjects Research Committee, IRB, and ethics boards, ensuring the submission of comprehensive, accurate, and uniform regulatory documents.13. Organize and manage auditing and monitoring visits.14. Co-manage the BWH IDS research pharmacy, overseeing the handling and delivery, and accountability of clinical trial medications (Investigational products / Study Drugs).15. Collect and input subject data into study case report forms and electronic data capture systems, promptly addressing queries.16. Conduct medical record screening of patients to identify eligible potential trial subjects, approaching them and their family members with trial-specific information for review/consideration.17. Assist in the recruitment of qualified and interested trial participants and scheduled and conducted follow-up subject clinical trial visits.18. Educate and inform clinical trial subjects and their families regarding clinical trial procedures, visit schedules, and communication with the research team.19. Provide clinical trial updates to subjects throughout the conduct of the clinical trial.20. Monitor personnel resource allocations and advised research leadership on factors affecting milestone delivery.21. Collaborate and liaise with ancillary departments and services as required to ensure the efficient execution of protocol components.22. Ensure the accuracy of case report forms, regulatory binders, and thorough trial records.23. Assist with preparing and submitting the final clinical trial report to the IRB for review.24. Prepare all documents, files, binders, and electronic data for sponsor-initiated or FDA audits.25. Administer more complex structured tests and questionnaires according to clinical trial protocols and utilize study-related technology and equipment as part of assessment procedures.26. Acquire, process, transport, and ship biological samples in accordance with the trial protocol requirements, following appropriate training.27. Organize and oversee regulatory binders, case report forms, source documents, and other study-related documents.Performs other tasks and responsibilities as directed.Qualifications
QUALIFICATIONS:1. Bachelor's degree in health related field. A professional medical degree is preferred.2. 6 years of Industry (domestic/international clinical trials) and/or Relevant Experience.3. Experience with computers and data management systems.4. Supervisory experience preferred.5. Hands-on human health care experience preferred.* Excellent outstanding interpersonal and communication abilities, demonstrating excellent proficiency in English, encompassing medical and scientific terminology.* Exceptional organizational skills and ability to organize time and priorities effectively and flexibility to handle multiple tasks and deadline pressures.* Proficient judgment skills, with ability to interpret information and initiate appropriate actions.* Rigorous attention to detail with accomplished documentation skills.* Ability to complete tasks with aggressive deadlines and competing priorities.* Ability to handle sensitive and confidential matters discreetly and to ensure confidentiality guidelines are maintained by staff.* Comfortable in hospital in-patient and out-patient environments.* Efficient with Windows based software including: Outlook, Word, Excel and Power Point.* Possess extensive experience in disease/health outcomes, translational/epidemiology research, and clinical trials.* Demonstrate strong problem-solving abilities, including information gathering, resource identification, and alternative brainstorming.* Display the ability to work effectively in a collaborative environment.* Manage diverse teams with varying skill sets, work styles, and professional roles.Clinical/research office environment with extended hours as needed to meet study deadlines.EEO Statement
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.Primary Location: MA-Boston-BWH Longwood Medical Area Work Locations: BWH Longwood Medical Area 75 Francis Street Boston 02115 Job: Research-Management Organization: Brigham & Women's Hospital(BWH) Schedule: Full-time Standard Hours: 40 Shift: Day Job Employee Status: Regular Recruiting Department: BWH Department Of Medicine / Cardiovascular Medicine Job Posting: Sep 30, 2024
The Sr. Project Manager of the Research Site (PMRS) is responsible for oversight of all operational aspects of the TIMI local MGB/BWH Clinical Research Site. This position reports directly to the TIMI Director of Operations and the TIMI Research Site Physician Director. The(PMRS) works directly with TIMI Physician Investigators to ensure the completion of each of the active studies contracted to participate. The (PMRS) manages multiple clinical trials, which involve human subjects recruited from multiple physician practices and clinical divisions within the MGB Healthcare System. This position includes oversight of all phases of clinical research, including study activation, enrollment, follow up, and closure. The (PMRS) is responsible for strict adherence to the each of the study protocols, meeting expected timelines, and submission of all required data elements as required by each study sponsor.The candidate must possess the ability to work independently in all phases of human clinical research and will routinely interact directly with both out-patients and hospitalized in-patients. The (PMRS) will be required to handle/process human blood, urine, and other biological specimens, as required. S/he must be knowledgeable of U.S. Food and Drug Administration (FDA) Guidelines, the Health Insurance Portability and Accountability Act (HIPAA) Regulations, and Good Clinical Practices (GCP) Guidelines.1. In collaboration with TIMI Principal Investigators (PIs) and study monitors, establishes, maintains and complies with policies and procedures for all assigned clinical trials.2. Is knowledgeable of all aspects of assigned department and trials and is competent to initiate evaluation of questions and/or problems. Assists with triaging issues to appropriate individuals possessing the resources/experience to answer the question or solve the problem.3. Directs all elements involved in the execution of clinical trials, encompassing pre-trial evaluation, trial commencement procedures, participant screening, recruitment, enrollment, appointment scheduling, patient follow-up, case report form completion, adverse event reporting, and study conclusion.4. Coordinate with the MGB Clinical Trial Office (CTO) and Pharmaceutical Sponsors in executing the Confidential Disclosure Agreement (CDA) and Clinical Trial Agreement(CTA), including budget for each clinical trial.5. Plan and conduct regular meetings with clinical trial leadership to engage in strategic planning discussions, explore operational improvement opportunities, and discuss management strategies.6. Possess in-depth knowledge of clinical research operations, project management, budget, contract administration, pharmaceutical sponsor, and institutional guidelines and requirements.7. Manage day-to-day operations, establish and maintain policies and procedures, monitor statistics, manage workflow and output, and coordinate space and infrastructure issues. Ability to engender these skills among staff.8. Lead and manage a team of clinical research professionals, including hiring and training, providing guidance, support, and mentorship as needed.9. Monitor budgets and expenditures, recommending necessary modifications to the principal investigator (PI).10. Develop SOPs, maintain essential documentation, and ensured compliance with current regulations.11. Manage relationships with contract research organizations (CROs), academic institutions, and other external partners to support clinical research initiatives.12. Act as a liaison between the MGB Human Subjects Research Committee, IRB, and ethics boards, ensuring the submission of comprehensive, accurate, and uniform regulatory documents.13. Organize and manage auditing and monitoring visits.14. Co-manage the BWH IDS research pharmacy, overseeing the handling and delivery, and accountability of clinical trial medications (Investigational products / Study Drugs).15. Collect and input subject data into study case report forms and electronic data capture systems, promptly addressing queries.16. Conduct medical record screening of patients to identify eligible potential trial subjects, approaching them and their family members with trial-specific information for review/consideration.17. Assist in the recruitment of qualified and interested trial participants and scheduled and conducted follow-up subject clinical trial visits.18. Educate and inform clinical trial subjects and their families regarding clinical trial procedures, visit schedules, and communication with the research team.19. Provide clinical trial updates to subjects throughout the conduct of the clinical trial.20. Monitor personnel resource allocations and advised research leadership on factors affecting milestone delivery.21. Collaborate and liaise with ancillary departments and services as required to ensure the efficient execution of protocol components.22. Ensure the accuracy of case report forms, regulatory binders, and thorough trial records.23. Assist with preparing and submitting the final clinical trial report to the IRB for review.24. Prepare all documents, files, binders, and electronic data for sponsor-initiated or FDA audits.25. Administer more complex structured tests and questionnaires according to clinical trial protocols and utilize study-related technology and equipment as part of assessment procedures.26. Acquire, process, transport, and ship biological samples in accordance with the trial protocol requirements, following appropriate training.27. Organize and oversee regulatory binders, case report forms, source documents, and other study-related documents.Performs other tasks and responsibilities as directed.Qualifications
QUALIFICATIONS:1. Bachelor's degree in health related field. A professional medical degree is preferred.2. 6 years of Industry (domestic/international clinical trials) and/or Relevant Experience.3. Experience with computers and data management systems.4. Supervisory experience preferred.5. Hands-on human health care experience preferred.* Excellent outstanding interpersonal and communication abilities, demonstrating excellent proficiency in English, encompassing medical and scientific terminology.* Exceptional organizational skills and ability to organize time and priorities effectively and flexibility to handle multiple tasks and deadline pressures.* Proficient judgment skills, with ability to interpret information and initiate appropriate actions.* Rigorous attention to detail with accomplished documentation skills.* Ability to complete tasks with aggressive deadlines and competing priorities.* Ability to handle sensitive and confidential matters discreetly and to ensure confidentiality guidelines are maintained by staff.* Comfortable in hospital in-patient and out-patient environments.* Efficient with Windows based software including: Outlook, Word, Excel and Power Point.* Possess extensive experience in disease/health outcomes, translational/epidemiology research, and clinical trials.* Demonstrate strong problem-solving abilities, including information gathering, resource identification, and alternative brainstorming.* Display the ability to work effectively in a collaborative environment.* Manage diverse teams with varying skill sets, work styles, and professional roles.Clinical/research office environment with extended hours as needed to meet study deadlines.EEO Statement
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.Primary Location: MA-Boston-BWH Longwood Medical Area Work Locations: BWH Longwood Medical Area 75 Francis Street Boston 02115 Job: Research-Management Organization: Brigham & Women's Hospital(BWH) Schedule: Full-time Standard Hours: 40 Shift: Day Job Employee Status: Regular Recruiting Department: BWH Department Of Medicine / Cardiovascular Medicine Job Posting: Sep 30, 2024