PRAHS 2018-50869 in United States

Operational Study Manager – Real World Solutions

Location – Blue Bell, PA or Remote US

The fundamental focus of this role is to manage study teams on a variety of Real World Solutions projects and achieve successful delivery of operational activities (site management, clinical monitoring and data review) by meeting internal and external client requirements.

Key Responsibilities:

Working on different global studies for the full project lifecycle, your key responsibilities will include:

  • To manage all study site related activities

  • To assume responsibility for project planning, set-up and conduct, communication and reporting and training of the study team

  • To supervise the site recruitment and patient-enrolment stages of the study

  • To liaise with the client for all site related issues, progress and risk

  • To create study tools and dashboards (specifically related to study status and site performance), to create project documents and templates including training materials

  • To plan on-site visits as required

  • To lead the study team of Site Management Associates and Clinical Research Associates across a region

  • To review and approve monitoring visit reports

  • To manage the operational budget, identify out of scope tasks and escalate as required

  • To manage and forecast resource needs to ensure project profitability

  • To collaborate with colleagues in our Biometrics department for delivery of data management deliverables, to oversee the clinical data review process and ensure quality control steps are planned and completed

  • Contribute to business development activities by participating in proposals and bid defenses when required

Qualifications:

  • Client management experience, including strong presentation skills and ability to speak to all aspects of clinical operations at project level

  • A robust knowledge of clinical research, preferably inclusive of Real World/Phase III, including study designs, GxP regulations and technologies / approaches associated with data management

  • 3+ years clinical research experience including site monitoring and/or management of study sites and clinical operations through the full project lifecycle

  • Experience leading professional staff in a clinical research environment

  • Read, write and speak fluent English

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required

Must Haves:

  • Client management, team leadership, knowledge of and experience in clinical research.

**PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

ID: 2018-50869

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/