PROGRAM DIRECTOR 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 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

CICL Leadership 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 tasks

Team Management

* Ability to work successfully in a collaborative environment
* Ability to manage diverse teams with different skillsets, work styles, and professional roles

Gets 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 attitude

Communication 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.

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