Project Director BWH Cardiovascular
Company: Brigham and Women's Hospital
Location: Boston
Posted on: May 4, 2024
Job Description:
Job Description - Project Director BWH Cardiovascular (3287496)
Project Director BWH Cardiovascular - ( 3287496 ) 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
core laboratory services for primarily large-scale global clinical
trials responsible for site training and interface as well as 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 Faculty
Directors, the Project Director functions as the CICL Operations
Director responsible for leadership and oversight of CICL clinical
trial project management, ensuring efficient lab-wide operations,
effective resource planning, adherence to study specific scopes of
work, as well as training, managing and developing project
management staff. PRINCIPAL DUTIES AND RESPONSIBILITIES
- Serves as the Primary Liaison with CICL Faculty Directors,
Technical Director, Program Manager, Quality Assurance Project
Manager, IT/Systems Director, and Administrative Director for
center-wide issues concerning staffing, resource projections,
database-related performance, and other issues that affect the
day-to-day quality and efficiency of the CICL.
- Serves as a member of the CICL Executive committee, leading
discussions related to ongoing trials.
- Serves as the Primary Liaison with the CICL Administrative
Director on center-wide directives, issues, and projects. Includes
reviewing new agreement and amendment scopes of work to ensure
understanding and agreement with technical team and
sponsors/CROs.
- Directs CICL operational staff on how best to run projects,
manage relationships and communication within a project, assisting
with the resolution of study-specific issues, and troubleshooting
as needed.
- Assigns new projects and delegates duties to CICL operational
staff.
- Train project staff to study (i.e., protocol, SOW, processes,
timelines, deliverables).
- Update "All Study" Documents with new and changing study
requirements. Includes internal and external reporting of CICL-wide
metrics tracking throughput, progress, capacity.
- Coordinate and run CICL staff meetings. Develop a meeting
agenda, maintain meeting minutes and attendance.
- Assist with the development of CICL PR materials and grant
proposals. Represents the CICL during bid defense meetings for new
proposals.
- Works with CICL QA Manager to review and respond to third party
vendor inquiries and questionnaires meant to assess and monitor
various aspects of the CICL and MGB infrastructure such as project
management processes, data security, research compliance, technical
capabilities.
- Responsible for direct oversight and management of on-site and
virtual audits, inspections and vendor qualifications and risk
assessments, including finalizing all associated documents,
responses and CAPAs.
- Liaises with QA Manager to develop and enhance employee
training systems and onboarding/offboarding processes and training
records.
- Responsible for monitoring the integration and compliance on
all CICL Policies and Procedures (P&Ps), including regular
review and revisions to various P&Ps as needed. Has overall
responsibility to ensure proper execution of CICL P&Ps
including major policies related to staff training, document
control, quality assurance, and data management.
- Provides other operational study-specific and lab-wide support
as per the CICL Directors.Project Management Oversight
Responsibilities:
- Study Start-up Management: Provides oversight and support to
Project Managers with study start-up deliverables. Includes
communication with Sponsors, Data Coordinating Centers, the CICL
Administrative Director and CICL technical staff to draft/finalize
study-specific documents.
- Day-to-day Trial Management: Assume the lead role in providing
clear and consistent leadership and organization of each trial with
a strong attention to detail. Includes monitoring each study's
assigned CICL team to ensure maximum efficiency, troubleshooting
issues, tracking volume and progress against study timeline, and
ensures compliance with study-specific Scope of Work and applicable
CICL SOPs.
- Support Project Managers and CICL study teams in the following
areas:
- Site training. Includes continually improving process,
materials, and presentations that are given.
- Reporting of study metrics to sponsors/CROs or internal
team.
- Study Close-Out Management.
- Other leadership/management support as needed.
- Liaise with Program Manager and Technical Director to set
priority and management timelines across 40+ ongoing trials.CICL
Data Management Oversight Responsibilities:
- Provides operational leadership and management of Data Analyst
to ensure data-related SOPs are followed. This includes leading
necessary improvements to study-specific data transfer process,
schedule, and format as needed.
- Provides operational leadership and management of Data Analyst,
Project Managers, and Technical Director to monitor data QA
process, adherence to CICL SOPs and study-specific requirements,
and ensure data transfer timelines are met.
- Databases: Contributes to the creation and management of each
study's CICL database. Suggests database improvements, when
necessary, throughout the duration of the trial. SUPERVISORY
RESPONSIBILITIES
- Provides daily supervision, guidance, and expertise for Data
Analyst, Project Managers, and Clinical Trial Coordinators.
- Reviews and approves CICL employee's daily schedule and time
accounting.
- Conducts staff performance reviews. Handles personnel issues
and escalates when appropriate.
- Plays a key role in interviewing and hiring potential CICL
employees, as well as transitioning staff between projects as needs
and timelines change.
- BS required, MS preferred.
- Minimum of 7-10 years directly related experience
required.
- Minimum of 2 years supervisory experience required.
- Formal training and/or certification in clinical research
(i.e., ACRP, SoCRA) as well as experience or training in human
resource management are highly desirable. SKILLS/COMPETENCIES
REQUIRED
- Ideal candidate is an established research professional
interested in managing a high volume of research studies and
project management staff.
- Experience and knowledge of Excel, PowerPoint, Word, Acrobat,
and Outlook.
- Basic knowledge of statistical software STATA.Planning,
Organizing and Coordinating
- Skilled in identifying and implementing opportunities to
improve efficiency of research operations and subsequently execute
improvements
- Time management skills with the capability to prioritize among
multiple requests from multiple individuals with the ability to
change direction in response to a fluctuating work environment
- Ability to delegate, prioritize, and assist others with
prioritizing study tasksTeam Management
- Ability to work successfully in a collaborative
environment
- Ability to manage diverse teams with different skillsets, work
styles, and professional rolesGets Results/Takes Initiative
- High personal work standards and sense of urgency about
results
- Ability to anticipate the needs of the group in a fast-paced
environment
- Problem-solving ability, including the ability to analyze
complex situations, identify resources, and imagine
alternatives
- Demonstrates initiative and identifies key priorities, even in
ambiguous situations with limited direction
- Ability to work effectively under pressure and within short
time constraints
- Consistently demonstrates a positive, "can-do"
attitudeCommunication Skills
- Excellent written and verbal communication skills
- Ability to represent the program with the utmost
professionalism and ability to build strong relationships inside
and outside the group
- Ability to clarify and distill complex issues to a variety of
stakeholders
- Demonstrated ability to lead discussions/meetings, and obtain
cooperation and support from team
- Cognizant and respectful of cultural differences in
communication approach WORKING CONDITIONS
The CICL supports a hybrid work model, however this position
requires regular in-office time to collaborate with CICL team
members. This position is M-F during core business hours. There is
no patient interaction in this position.
- BS required, MS preferred.
- Minimum of 7-10 years directly related experience
required.
- Minimum of 2 years supervisory experience required.
- Formal training and/or certification in clinical research
(i.e., ACRP, SoCRA) as well as experience or training in human
resource management are highly desirable. SKILLS/COMPETENCIES
REQUIRED
- Ideal candidate is an established research professional
interested in managing a high volume of research studies and
project management staff.
- Experience and knowledge of Excel, PowerPoint, Word, Acrobat,
and Outlook.
- Basic knowledge of statistical software STATA.Planning,
Organizing and Coordinating
- Skilled in identifying and implementing opportunities to
improve efficiency of research operations and subsequently execute
improvements
- Time management skills with the capability to prioritize among
multiple requests from multiple individuals with the ability to
change direction in response to a fluctuating work environment
- Ability to delegate, prioritize, and assist others with
prioritizing study tasksTeam Management
- Ability to work successfully in a collaborative
environment
- Ability to manage diverse teams with different skillsets, work
styles, and professional rolesGets Results/Takes Initiative
- High personal work standards and sense of urgency about
results
- Ability to anticipate the needs of the group in a fast-paced
environment
- Problem-solving ability, including the ability to analyze
complex situations, identify resources, and imagine
alternatives
- Demonstrates initiative and identifies key priorities, even in
ambiguous situations with limited direction
- Ability to work effectively under pressure and within short
time constraints
- Consistently demonstrates a positive, "can-do"
attitudeCommunication Skills
- Excellent written and verbal communication skills
- Ability to represent the program with the utmost
professionalism and ability to build strong relationships inside
and outside the group
- Ability to clarify and distill complex issues to a variety of
stakeholders
- Demonstrated ability to lead discussions/meetings, and obtain
cooperation and support from team
- Cognizant and respectful of cultural differences in
communication approach WORKING CONDITIONS
The CICL supports a hybrid work model, however this position
requires regular in-office time to collaborate with CICL team
members. This position is M-F during core business hours. There is
no patient interaction in this position. 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 Work Locations 75 Francis St Job Job
Professional/Managerial Organization Organization Brigham & Women's
Hospital(BWH) Schedule Standard Hours 1 Shift Shift Day Job
Employee Status
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Keywords: Brigham and Women's Hospital, Billerica , Project Director BWH Cardiovascular, Executive , Boston, Massachusetts
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