Project Manager, Cardiology
Brigham & Women's Hospital(BWH)

Job Info

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The BWH Amyloidosis program is an internationally-recognized multidisciplinary program dealing with the uncommon disease, amyloidosis. The Research Project Manager (RPM) will have the opportunity to oversee cutting-edge industry and investigator-initiated clinical trials while interfacing with pharmaceutical / biotech experts, research organizations and physician investigators in a multidisciplinary fashion.

Responsibilities:

The RPM will also be responsible for the team's execution on a daily basis, of the procedural, managerial and policy decisions made for the studies. Executes and coordinates daily clinical research activities across a number of protocols. Participates in all decisions made for the study and identifies modifications of existing policies and procedures. Works across departments and specialties in multidisciplinary trials. Responsible for budget oversight, training other team members, developing and keeping SOPs current for the unit and participating in supporting grant writing and proposals overseen by the director. Oversees the day to day activities of clinical trial coordinator(s), research assistant(s) and CCI/temporary support staff as needed, depending on workflow fluctuations.

1. Trials operations - The project manager is responsible for all operational aspects of clinical trial oversight including the timely delivery of each study within budget boundaries. Responsible for the coordination and implementation of research design processes and study protocols for multiple clinical trials.

a. Ensures that required regulatory documents are completed by the team. Works with the PI and the trial sponsor/contracted research organization to complete trial agreements. Communicates effectively and promptly with sponsor contacts and with the PI regarding agreement language. Works to proactively identify issues that may delay execution of completed agreements. Emphasizes and facilitates communication between relevant stakeholders in the pre- and post-enrollment phases of studies.

b. Oversees applications to the IRB, including new application, amendment, continuing reviews, SAE's, etc. for all new and existing study proposals. Ensures that protocols move through the system and receive approval as quickly as possible. Oversees IND and FDA filings for investigator-initiated studies when appropriate.

c. Working in concert with the Director, Principal Investigator and/or Clinical Trials Coordinators, develops and implements patient recruitment strategies and ensures recruitment goals are met.

d. Defines and monitors key performance indicators and departmental metrics for Clinical Operations and identifies opportunities to optimize processes, procedures (SOPs, Work Instructions) and cost.

e. Provide efficient updates on trial progress to the Director of Clinical Trials, Department Administrator, and/or Administrator.

f. Attends regular scheduled internal clinical trials meetings as well as any other management meetings at the discretion Amyloidosis Program senior physician staff and/or Department Administrator. Attends or arranges attendance at investigator meetings, if available, together with or in the absence of a PI, Co-I or other qualified team member.

g. Develops, organizes, and/or maintains the study database for individual studies. Responsible for data validation and quality control. In conjunction with Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.

h. Serves as the primary contact for outside vendors utilized to ensure efficient operation of the study.

i. Directly responds to inquiries regarding study protocol and policy. Serves as liaison to internal and external population.

i. Must be accessible to study participants in order to screen adverse events, concerns and questions related to the investigational drug protocol.

ii. Must be easily reachable and 'on-call' during assigned work hours to provide study information, screening and, when applicable, point-of-service assistance in carrying out approved protocols.

j. Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions. Recommends changes to research protocols or to unit standard operating procedures. Determines specific division of workflow required in each study in order to complete the study efficiently, compliantly, and with the welfare and experience of the patient being the paramount concern.

k. Attends and participates in investigator meetings, site visits and regular recurring meetings with trial coordinators and study monitors. Ensures all required documents are ready for any site visit or monitor visit.

Financial Responsibilities

a. Monitors and reports on the financial performance of each study.

b. Reconciles the financials of every trial each month. Provides PI, Director of Clinical Trials Unit, and Administrator on a monthly basis; reviews financials with team at operational meetings as appropriate. and the rest of the team with financial reporting

c. In coordination with Department Administrator and Grant Administrator, manages the development and oversight of Unit's budget.

d. Ensures all invoiceables are captured and invoiced in a timely manner. Tracks invoices and subject stipends in OnCore and Forte.

Human Resources

a. Directly manages Clinical Unit for Research and Innovation in Trials staff with responsibility for staff training, performance management, setting individual employee goals and career growth opportunities for staff. On a daily basis, ensures the execution of the procedural, managerial, and policy decisions made for the study.

b. Supervises 2-4 research assistants; Incumbent is responsible for making sure they are meeting their job responsibilities and for providing redundancy and backup when needed.

c. Maintains, oversees and dictates team responsibilities, with particular focus on regulatory elements / compliance, timelines, deliverables, and ensuring that we are appropriately managing internal and external delay in the set up process for clinical trials. Troubleshoots delays and interfaces with complex network of internal and external relevant parties to effectively execute aforementioned deliverables.

d. Depending on the number of clinical trials we have at any given point the RPM may need to function in a CTC capacity at times. This includes all potential coordinator / RA functions, but is not limited to, initiating and maintaining contact with study participants, screening applicants / attending and preparing for trials visits, monitor /site visits, scheduling patient visits, performing clinical tests such as phlebotomy, EKGs, etc, as well participating in clinical data collection and obtaining biological specimens.

e. Holds regular staff meetings to get reports on current progress in each trial. Reports this progress, successes and delays, to the PI and DA.

f. Should anticipate and make every effort to prevent potential protocol deviations due to scheduling conflicts, including inability of study staff to be present at scheduled visits (illness, planned vacation, holidays); and arrange appropriate coverage in advance of aforementioned conflicts.

g. Maintains appropriate GCP / CITI, study-specific and other required trainings for all faculty and staff participating in clinical trials activities. Ensures training for all relevant staff is up to date and in compliance.

4. Participates in grant writing, proposal writing and/or manuscript development.

5. All other duties as assigned.

Qualifications

• BS required, Master's degree or higher strongly preferred.
• Certification in clinical trials management strongly encouraged.
• Minimum of 5 years of progressively more responsible experience in a research related field. Experience managing a team working across a matrix environment is preferred. Prior experience with financial management and data collection systems.
• Clinical project management experience is preferred.
• More than 5 years of experience with exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork regulatory paperwork, consenting and interacting with study subjects, strict protocol adherence and archiving are required.
• Familiarity with working in a large healthcare organization / academic center encouraged.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Excellent interpersonal skills are required for working with the study participants and multiple parties involved in the trials process.
• Flexibility, a strong ability to multi-task, problem-solve and strong interpersonal skills are highly valued.
• Comfort interacting with patients / research subjects and their families in a professional and reassuring manner.
• Excellent organizational skills and ability to prioritize a variety of tasks.
• Careful attention to detail.
• Ability to demonstrate professionalism and respect for subjects' rights and individual needs.
• Ability to effectively manage individuals at various levels within the team is highly valued.
• Comfort interacting with patients / research subjects and their families in a professional and reassuring manner.
• Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
• Certification in phlebotomy or certification within three months is strongly encouraged.
• Excellent oral and written communication skills.
• Knowledge of clinical research protocols.
• High degree of computer literacy.
• Knowledge of data management programs.

EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.

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