Coordinating Center Project Manager, Center for Clinical Investigation, Hybrid

GENERAL SUMMARY/ OVERVIEW STATEMENT:

We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the BWH Center for Clinical Investigation (CCI), and collaboratively with PIs from Massachusetts General Hospital and University of Texas Southwestern. The candidate will work with Department Managers, the Finance Manager, and Principal Investigators and under general supervision from the Research Operations Director.

The mission of the CCI is to strengthen the culture for clinical research at the Brigham and Women's Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators.

A specific exciting multi-year clinical trial in startup phase relates to antibiotic allergy and is funded by the National Institutes of Health. The Project Manager will play a key role in the execution of this study that is being conducted in about 6 US sites.

**When applying, please include a cover letter along with your resume**

For more information regarding our group, please visit Center for Clinical Investigation.

Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes:

* Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.

* Meeting with the research team regularly to review trial projects, timelines and action items

* Contribute to the strategic development of the multicenter trial

* Developing committee charters and run meetings as needed

* Foster a team environment

* Lead additional special project oversight as requested

Leadership and Strategy

• Formulates the vision and leads both the short and long term strategic and operational planning for CC
• Develops and implements the infrastructure required to achieve the goals
• Builds and convenes trial oversight committees such as Steering Committee, Executive Committee, and Advisory Boards (as needed)
• Provides clear channels of communication, delegation, and accountability for effective supervision and problem solving

• Leads or participates in a variety of committees

Operational Management

Develop and maintain the infrastructure of a multicenter clinical trial by supporting the design, planning, and management activities, including the following:

Regulatory

* Submit IRB Applications and required reporting

* Manage site regulatory documents and Trial Master File (TMF)

* Manage ClinicalTrials.gov postings

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Study documents

* Assist in preparation of protocol and informed consent forms

* Assist with recruitment materials

* Oversee preparation and maintenance of Manuals of Procedures

* Oversee site and staff training materials

* Manage study portal and access to study documents and trial materials

Data management

* Assist in developing Case Report Forms

* Assist in development study conduct reports

- Distribute reports

Safety and Monitoring (as applicable)

* Develop Safety Monitoring plan

* Review safety data

* Report SAE/SUSARS to IRB

* Develop site initiation and monitoring plan

* Oversee interim monitoring

* Conduct site close-out

Site activation, training, and trial conduct

* Site feasibility assessment development and implementation

* Approve site activation

* Provide site training and initiation

* Investigation/remediation of site non-compliance

Study closure and analysis

* Site closure and reporting

* Monitor return / destruction of unused IP (if applicable)

* Notification of study closure to IRB

* Prepare and submit Final Study Report

* Archival of site records including site TMF

* Oversee publication of study findings

Administrative

- Maintaining a list of all participating investigators, their research teams, legal contract teams and administrative teams.

- Organizing regular meetings of the tr trial members, setting up agenda ahead of the meeting, recording minutes at each meeting and taking key notes from each meeting including voting and consensus and following up on all discussions. Record action items and ensure execution and follow-through.

- Updating clinicaltrials.gov and other websites monthly and as needed

- Schedule and organize Retreat/Symposium as needed.

- Assist in development written materials for internal and external audiences in alignment with program and trial goals

Quality and Process Improvement

* Oversees development, implementation and administration of quality assurance plan This includes continuous development of metrics and tools to monitor, trend, and report performance measures

* Facilitates and/or participates in communication with internal and external staff as it relates to training, performance measures, and quality assurance

Personnel Management

• Recruits and retains staff that reflects and support the mission
• Builds and trains a team of clinical research professionals to support trial and CC conduct
• Creates an environment of mentorship and career development

All other duties, as assigned.

QUALIFICATIONS:

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    • PhD preferred in Translational Medicine or Regulatory Affairs
    • At least 3 years of clinical research experience
    • Ideally, minimum of 2 years working within an academic clinical trial coordinating center or regulatory management
    • High proficiency with Microsoft Office, particularly with Excel
    
    
    
    
  
  
  
  

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Outstanding organizational skills are necessary to manage detailed information and priorities across competing timetables and responsibilities. Ability to plan for the timely and successful completion of short- and long-term objectives.

* Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency, including senior hospital leaders, division faculty and support staff, representatives of other BWH offices, collaborating institution officials, granting agencies (NIH, industry and foundations) representatives, and vendors.

* Requires the ability to work independently to ensure protocol review, implementation and ancillaries processes run smoothly.

* High degree of analytic ability to manage the financial and human resources aspects of the position.

* Interpersonal relationship skills needed to collaborate with others and work with functional group managers, many hospital-wide department heads, administrators, and physicians in a positive and collegial fashion.

* Comfortable using systems to create, update, maintain and disseminate data and reports.

• Demonstrated project and program management skills; ability to prioritize initiatives and ensure timely execution and follow through
• Proven ability to balance "big picture" strategic planning with specific and detail focused deliverables
• Skilled and knowledgeable liaison between high level academics, industry, and philanthropic partners
• Demonstrated time management and organization skills
• Knowledge of current and developing pre-clinical and clinical research trends
• Sound interpersonal skills
• Works well independently and in groups; displaying initiative and diplomacy while maintaining important work relationships
• Demonstrated ability to successfully manage multiple projects

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.