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28 days old

Executive Director, Clinical Science

WIRB-Copernicus Group (WCG)
Wayland, MA 01778

General Information

Location: Remote, Wayland, MA

Organization: Analgesic Solution

Job Type: Full Time - Regular

Description and Requirements

The position of Executive Director, Clinical Science will be responsible for providing clinical and scientific leadership in support of our central statistical monitoring service and other category leading clinical trial training and tools.    Primary area of expertise will be clinical research methodology, measurement, psychometrics, supporting clinical trials sites and subjects in providing accurate data, a reasonable level of statistical expertise, risk-based and central statistical monitoring and training.

The Executive Director, Clinical Science has the experience and gravitas to lead project specific QDSS data analysis services across multiple divisions of the larger parent company. This person interacts with similar professionals across the WCG family of companies and rises to a level of scientific leadership in the profession in relation to Analgesic Solutions scientific developments and services.  He/she has the capacity to distill and present customer experiences to product development, business development and marketing to assist in product advancement within each of these disciplines.

Duties and Responsibilities:

  • Lead development of customer-centric central statistical monitoring service by providing customer input, clinical and methodological input to product development, business development and marketing

  • Understand how the Quantitative Data Surveillance System (QDSS) works, how to identify performance problems, perform root cause analyses, and match the problem to an intervention, interact directly with sites to assess problems and deliver interventions, and guide the central statistical monitors.

  • Optimize the presentation of data, insights, and recommendations to sponsors

  • Assist in development and defense of proposals to prospective customers

  • Responsible for managing implementation phase of QDSS with customer and for participating in associated regular trial data analysis and development of subsequent recommendations

  • Identify performance/quality issues to develop appropriate remediation plan

  • Supervise development and delivery of project deliverables, including final QDSS and Training reports

  • Provide direct training to investigators, study coordinators, and other clinical trial participants as needed

  • Provide scientific and clinical leadership to support growth of QDSS and training franchises 

Education Requirements:

  • Ph.D., FD, or equivalent in Research Psychology, Biostatistics, Clinical Pharmacology, Education, or other relevant discipline. 

Qualifications:

  • 10+ years experience in similar role in the Clinical Research industry

  • Demonstrated knowledge of GCP, ICH and FDA guidelines and regulations

  • Expertise in clinical research methodology, psychometrics, scale development and validation, basic biostatistics, and the practical running of clinical trials is a must

  • Demonstrated understanding of the clinical trial management process including site selection and experience working with clinical research sites

Categories

Posted: 2020-08-25 Expires: 2020-10-22

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Executive Director, Clinical Science

WIRB-Copernicus Group (WCG)
Wayland, MA 01778

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