Project Manager BWH Cardiovascular

The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women's Hospital, a Harvard-affiliated hospital. The CICL provides echocardiography (echo) core laboratory services for primarily large-scale global clinical trials, responsible for site training and interface as well as quantitative echo analysis of images received. The CICL works primarily with sponsors, CROs, and clinical trial sites which send echos directly to the CICL. There are approximately 40 staff supporting 40+ clinical trials ongoing at any given time with a typical volume of 1000 - 1500 echos received each month.

Reporting to CICL Operations Director, the Project Manager is responsible for independently managing all aspects of their assigned trials including image receipt and processing, data transfer, and reporting.

PRINCIPLE DUTIES AND RESPONSIBILITIES

Project Management:

• On a daily basis, provides clear and consistent organization of each assigned trial's status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks, monitoring project timelines and associated reporting of study-specific metrics to sponsors/CROs.
• Participates in CICL-related decisions that impact the study.
• Ensures smooth and efficient internal day-to-day operations for numerous assigned studies. This will include serving as the primary liaison with Sponsor/CRO and CICL leadership for day-to-day issues, progress reporting, and attending study specific meetings.
• Represents the CICL as site Investigator Meetings and imaging-centered training sessions for site staff. Includes both development of training materials, tracking attendance, and presenting data about the CICL and applicable study.
• Responsible for the oversight of all study files.
• Maintains appropriate document control standards per MGB and CICL SOPs.
• Processes incoming subject/study documents and images for accuracy and completeness. Includes troubleshooting technical issues pertaining to images received including repairing image files and removing PHI from images and following associate PHI breach protocols.
• Manages distribution of technical feedback to sites such as sonographer certification, eligibility confirmation, and quality feedback. Includes working with sites to distribute and resolve CICL-generated queries.
• Assists technical teams to prioritize timelines and ensure adequate progress is being made to meet data transfer deadlines.
• Reports study metrics to Business Manager for invoicing purposes and other reporting as requested.
• Supports sites with questions regarding study protocol, queries, and the image submission process. Responds to questions submitted to the CICL site line and helpdesk email.
• Leads on-site monitoring and auditing visits. Includes management of associated vendor qualification questionnaires.

Information Systems:

• Liaises with CICL staff and MGB Information Systems/Information Security personnel for issues as they pertain to CICL computer systems, troubleshooting, data security, software, infrastructure improvement, quality improvement, and workstation issues.

Data Management:

• Liaises with CICL staff to support the creation of new, and management of existing CICL databases.
• Responsible for generating both study-specific progress reports and data as well as generating center-wide cumulative data and progress reports.
• Works with Study Sponsors and/or Data Coordinating Centers along with the CICL Clinical Data Coordinator to ensure proper data management, including data transfers of final data to study Sponsors.

General:

• Facilitates the implementation and ongoing process improvement of established CICL Policies and Procedures; responsible for monitoring the effectiveness and adherence to policies, generation of new policies, prn.
• Provides other support as per the CICL Directors as it relates to the overall research scope of the CICL.
• Attends CICL Operational and Team meetings, providing necessary study-specific updates.
• Provides back-up coverage for CICL Operational Team as needed.
• Other duties as assigned.

• BA/BS degree in biological sciences or health administration.
• Research professional with at least 5 years' experience in clinical research and/or trial project management.
• Knowledge of FDA regulations, ICH and GCP guidelines concerning human subject research especially as they relate to computer systems/security, disaster recovery and regulatory compliance of research core labs.

SKILLS/COMPETENCIES REQUIRED

• Given this is a project environment and multiple projects will be assigned, and given that each project will have unique project demands, staff, deliverables and timeline, the ideal candidate is:
• highly organized and systematic in work processes
• self-motivated and proactive; able to identify, track, and drive issue resolution with little or no supervision or prompting
• able to function at a high level in a dynamic and busy environment
• able to take direction from, as well as influence and establish strong working relationships with a wide variety of individuals at all levels; ie. other Center project staff, technical staff, Directors, enrolling sites, Sponsors and other affiliate groups
• very dependable and able to demonstrate a respect for the importance of how work practices affect data quality
• able to communicate concisely and effectively, without undue delays, both verbally and in writing
• a clinical research professional, or aspires to become one, with an interest in cardiovascular medicine, human subject research and clinical trial project management.

SUPERVISORY RESPONSIBILITIES

None however job will require assigning and overseeing work performed by Clinical Trial Coordinators assigned to each study.

WORKING CONDITIONS
The CICL supports a hybrid work mode. This position requires in-office collaboration with CICL team members at least 3 days a week. This position is M-F during core business hours.

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.