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Senior Clinical Project Manager

Company: OM1, Inc.
Location: Boston
Posted on: January 16, 2022

Job Description:

OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused 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.
Senior Clinical Project Manager who will be implementing agreed upon strategies for the management of a variety of different study types (ranging from analytics to Next Generation Registries to data deliveries) with pre-specified timelines and budgets at the project and/or Program level. These projects are typically large, complex, full-service studies. The SPM leads the project team and is responsible for the successful conduct and completion of the project to the contracted budget and timelines and ensuring the quality of the project according to ICH/GCP (as applicable), OM1 and/or Client SOPs, guidelines and requirements. The SPM will serve as the point of contact for internal/external customers and act as the liaison to the Client for study related issues. The SPM is involved in departmental improvement processes and initiatives, supports Business Development and proposal creation and acts as a mentor or supervisor for less experienced Client Services staff.
Supervisory Responsibilities:

  • Mentor and support junior staff members.
  • Provide oversight responsibilities on complex projects to ensure deliverables meet OM1 quality standards
    • Leads Project, Programs or initiatives that may include data delivery, data analysis, data collection and management, statistics, report/protocol writing, medical affairs and agency presentations.
    • Manages project goals within Client Services including startup activities focused on site identification, contract and budget, patient enrollment, the project plan and associated timelines.
    • Within a matrix environment, oversee all deliverables, milestones and deadlines related to assigned studies/projects, including site enrollment, regulatory and IRB approvals, and patient enrollment and follow-up.
    • Provides monthly status reports to Client and/or internal purposes and financial reporting requirements, invoice generation and revenue review, timesheet review, and pass-through cost review as applicable.
    • Develop, Review and/or maintain clear study related documents, ensures all critical study documentation is collected and filed in TMF/eTMF (as applicable) so that we are audit ready.
    • Manage the preparation, maintenance and traceability of central and site files (TMF/eTMF, as applicable) for projects with the functional leads.
    • Adhere to internal change management processes per our internal SOPs, WP and project specific process. Including project specific quality initiatives to assure that projects are audit ready.
    • Adhere to departmental and organizational processes and standards. This includes the establishment of study specific processes/standards and oversight of project compliance (e.g., Project, Risk, Communication, and Training Plans) within a global Project Management Plan.
    • Identification, coordination and management of external providers/vendors as applicable.
    • Deliver presentations at internal staff meetings, professional meetings, and to existing clients
    • Attend off-site meetings and conferences, as needed
      • Proven ability working independently with little guidance, anticipating next steps, and taking initiative in a project leadership role
      • 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
      • Strong performance under pressure and ability to adapt
      • Proficiency with Microsoft Suite, including Word, Excel and PowerPoint required
      • Excellent verbal and written communication skills
      • High degree of professionalism
        Education and Experience:
        • BA/BS required; MPH or related degree preferred but not essential
        • Minimum of 5 years experience in a health care and/or clinical research setting, including exposure to pharma services e.g., CROs or analytic services
        • Experience with Google Apps preferred

          OM1 is an equal employment opportunity employer and considers qualified applicants without regard to gender, sexual orientation, gender identity, religion, race, veteran or disability status. At OM1 ensuring that people feel respected, valued, and included is essential to our success. We are committed to working together to provide a work environment that embraces the principles of diversity, equity, and inclusion.

Keywords: OM1, Inc., Boston , Senior Clinical Project Manager, Healthcare , Boston, Massachusetts

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