Director, Clinical Project Management

4 weeks ago

boston, United States OM1, Inc. Full time

OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics to transform records from a diverse set of sources into enriched, research grade data which allows us to generate unique insights in a variety of disease areas.


The Director, Clinical Project Management works cross-functionally with the Epidemiology, Biostatistics, Clinical Informatics, Engineering, and Data Science teams to drive the scoping and execution of new projects. This position plays a key role in strategic planning, implementation, and operational oversight to enable OM1’s success and growth.


What You'll Do at OM1:

  • Overall management of the Client Services department including proactive identification of resourcing needs, monitoring FTE workload relative to billability expectations, screening and hiring of candidates, training on departmental responsibilities and expectations, and establishing comprehensive retention strategies to keep staff motivated and productive. Including, providing mentorship and guidance to project management staff, fostering a culture of continuous learning and professional development.
  • Oversee the Project Management team in ensuring high quality, on-time deliverables, proactive communication, and efficient issue resolution.
  • Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management
  • Oversee the creation and delivery of client-facing materials, including presentations, agendas, minutes, and reports
  • Ensure cross-functional internal teams are provided with the information and tools needed to ensure their ability to launch and support projects both initially and throughout the project duration
  • Ensure contractual obligations to each client are understood and those expectations are met (with the goal to exceed), while minimizing unnecessary scope creep and ensuring efficient resource utilization
  • Establish, as necessary, and manage processes, key performance indicators, and quality standards to ensure optimal client service and operational quality and efficiency.
  • Identify opportunities for process improvement and implement best practices to enhance the efficiency and effectiveness of clinical trial operations
  • Support the development and maintenance of Client Services-specific Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure products and services are developed and delivered consistently to meet customer and applicable statutory and regulatory requirements.
  • Attend off-site meetings and conferences, as needed
  • Support Business Development efforts by providing input into proposals and related budgets as well as representing OM1 in meetings with prospective clients


What Experience You'll Bring

  • Ability to communicate with both senior executives and technical teams; excellent written, verbal and presentation skills
  • Must be comfortable working in a fast-paced and dynamic environment, with the ability to complete complex tasks with frequent interruptions
  • Extremely organized; comfort with complex and inter-dependent workstreams
  • Ability to work well in cross functional teams, including engineering, product management and research
  • Proven people management skills
  • Have a robust understanding of healthcare departmental/clinical operations, workflow, policies, and procedures
  • Regulatory Knowledge: Determine the candidate's understanding of relevant regulations and guidelines governing clinical trials, such as GCP, ICH, and FDA regulations.
  • BA/BS required; Minimum of 8 years experience in a health care and/or clinical research setting, including exposure to pharma services (e.g. CROs or analytics) in Real World Evidence.


What's Nice to Have

  • PMP, preferred but not essential
  • MPH or related degree preferred but not essential

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