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Senior Director, Clinical Operations / RWE Solutions

Location: Durham
Posted on: November 22, 2021

Job Description:

Target RWE is open to remote candidates.SummaryThe Senior Director, within the Evidence Solutions team, has the responsibility for strategic operational planning, oversight and/or execution of data generation activities associated with our disease communities and unique industry partner projects. The Senior Director serves as an integral member of the Evidence Solutions Team and provides guidance on operationalizing approaches to support research using real world data generation. Leads the daily operations of multiple assigned clinical programs and associated deliverables with a thorough understanding of the operational and strategic aspects of the project.What You'll Do

  • Direct key initiatives and tactics to support Evidence Solutions including budgeting and planning, synopsis/protocol coordination, site selection and oversight, alignment of timelines and plans, etc.
  • Create and implement project guidance documents including protocol (co-developed), clinical monitoring plan, key data curation guidelines, study reference manual, training material.
  • Support assessment of resource needs related to data generation activities and CMP deliverables
  • Oversee all aspects of the clinical operations of the study including site identification, study start up, activation, and enrollment.
  • Manage and lead the project team.
  • Apply best practices of GCP across multiple study types
  • Oversee the generation and delivery of a quarterly status report.
  • Solicit and qualify external vendors (i.e. central laboratory, pathology)
  • Perform other duties as assigned.Your Education and ExperienceBachelor's or Master's degree, preferably in medical or biological sciences or discipline associated with clinical research. 10 years of related pharmaceutical or biopharmaceutical industry experience, with at least 2 of those years in a clinical operations lead or manager role. Experience with real world data studies and site management outside of the U.S. preferred.Knowledge, Skills & AbilitiesExcellent interpersonal and communication skills, both written and oral. Excellent computer skills in Microsoft environment (Microsoft Excel, PowerPoint and Word). Strong organizational skills. Ability to work independently as part of a cross-functional team with minimal direction. Ability to be a high achiever with strong track record of delivering. Ability to problem solve in non-traditional ways. Demonstrated ability of initiative, teamwork and accountability. Ability for a strong attention to detail and accuracy. A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines. Ability to follow guidelines and procedural documents.Why Target RWE
    • Fast-moving, high-growth, biotechnology company
    • The opportunity to impact healthcare and improve peoples' quality of life
    • Work remote / from home culture that is flexible and no-nonsense
    • Smart and easy-going colleagues
    • Competitive healthcare benefits (employees are eligible to enroll on their first day of employment)
    • 401(K) with a company match
    • Generous time off packageApplicants must be authorized to work in the United States without sponsorship.

Keywords: TARGET PHARMASOLUTIONS, Durham , Senior Director, Clinical Operations / RWE Solutions, Executive , Durham, North Carolina

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