Clinical Affairs Specialist


Principal Duties and Responsibilities

  • Support and establish clinical research strategy 
  • Design, plan and implement the clinical research studies 
  • Understand and ensure compliance with policies and procedures required for clinical validation within the Partners HealthCare system 
  • Prepare Internal Review Board (IRB), data sharing committee, and other documentation as required by the clinical investigation and regulatory requirements 
  • When appropriate, recruit and qualify clinical investigative sites 
  • Prepare and report on the status of clinical investigations internally and externally 
  • Analyze data acquired during the course of the clinical investigation, prepare reports and presentations based on clinical findings 
  • Support product leaders by interfacing with end users to elicit and build empathy with voice of customer, building intimate knowledge of user workflow, pain points, and product needs in order to drive product usability and acceptance 
  • Use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration 
  • Other duties as assigned 

 

Qualifications

  • BA/BS (or higher level of education), ideally in a quantitative discipline, biological science, or technologist/nursing is required 
  • 5+ years experience in clinical trial planning, support, and coordination in medical devices or software is required 
  • Demonstrable experience with and comprehension of the major considerations of clinical trial study design is required 
  • Comfort with basic statistics and proficiency with Excel, PowerPoint and database software are required 
  • Demonstrable presentation skills required (e.g., storyline and presentation development) 
  • Deep familiarity with the practice of medicine, medical terminology and clinical workflows, including medical imaging diagnostics, pathology, and clinical laboratory medicine 
  • Experience in a startup environment, and/or exposure to the fields of data science and machine learning are strongly preferred 
  • Ability and willingness to obtain required hospital credentialing to gain appropriate access to required areas of the investigational site

 

Skills/Abilities/Competencies Required

  • Strong sense of urgency and proactiveness – ability to manage and drive work and agenda independently, and source inputs from manager and team as needed 
  • Strong analytical, planning, organization and time management skills 
  • High attention to detail and understanding of end-to-end processes 
  • Demonstrated eagerness to move out of existing comfort zone and learn new skills 
  • Self-motivated, independent and possesses the ability to learn quickly 
  • Excellent and succinct written and oral communication skills; 
  • Excellent interpersonal/team effectiveness skills 
  • Ability to build consensus among cross-functional teams and influence decision making within senior-level audiences 
  • Ability to effectively conduct meetings and lead and facilitate large working sessions with all levels of staff 
  • Excellent interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization including both technical and non-technical personnel 
  • Proven track record of executing challenging analytic and problem solving projects to drive measurable business value 
  • Exceptional problem solving skills 
  • Ability to structure complex, ambiguous, and potentially challenging business issues for center leadership and to develop compelling, insightful recommendations 
  • Ability to gather and analyze large amounts of information quickly and accurately, and synthesize findings into an actionable summary and clear next steps 
  • Strong project management skills; knowledge of process and project planning best practices 
  • Willingness and ability to juggle numerous projects simultaneously, and respond to changing priorities 
  • Ability to function effectively and independently in a fast-paced environment, organize and prioritize work independently, and meet tight deadlines 
  • Willingness and ability to handle confidential matters with utmost discretion 
  • Ability to successfully collaborate with others of different skill sets, backgrounds an levels within and external to the organization