Clinical Research Operations Manager, Brigham and Women's Hospital

hace 2 semanas

Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo
Job Description

We are seeking a highly organized and detail-focused individual to serve as a Project Manager in the BWH Center for Clinical Investigation, collaborating with Principal Investigators from Massachusetts General Hospital and University of Texas Southwestern.



Responsibilities:


  • Develop and maintain the infrastructure of a multicenter clinical trial by supporting design, planning, and management activities
  • Provide strong leadership as a liaison between investigators, sites, and sponsors
  • Meet with the research team regularly to review trial projects, timelines, and action items
  • Contribute to the strategic development of the multicenter trial
  • Foster a team environment and lead additional special projects as requested
  • Operational Management: Develop and maintain the infrastructure of a multicenter clinical trial by supporting the design, planning, and management activities
  • Regulatory: Submit IRB Applications and required reporting
  • Manage site regulatory documents and Trial Master File (TMF)
  • 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: 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
  • Site activation, training, and trial conduct: Site feasibility assessment development and implementation
  • 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 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 of 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
  • All other duties, as assigned


Qualifications:


  • At least 3 years of clinical research experience
  • Ideally, minimum of 2 years working within an academic clinical trial coordinating center
  • High proficiency with Microsoft Office, particularly with Excel
  • Outstanding organizational skills
  • Ability to plan for the timely and successful completion of short- and long-term objectives
  • Excellent verbal and written communication skills
  • 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


Education:


  • Bachelor's degree required, Master's preferred
  • 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.

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