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Senior Project Manager, Clinical Research

Senior Project Manager, Clinical Research

Job Title: Senior Project Manager, Clinical Research
Contract Type: Permanent
Location: Georgia
Industry:
Salary: Negotiable
Reference: AM10012_1488302121
Contact Name: Amy Ma
Contact Email: a.ma@sciproglobal.com
Job Published: February 28, 2017 17:15

Job Description

PRINCIPAL RESPONSIBILITIES

  • Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.
  • Liaison between company, investigational sites, and CROs (as applicable) to coordinate and document clinical research studies. Respond to written and telephone inquires from investigational sites, as applicable.
  • Collect, query, analyze, and present clinical data. Develop and maintain any applicable clinical research databases as necessary.
  • Identify required biocompatibility testing, work with legal to develop a contract and ensure timely completion and accuracy of final report.
  • Conduct basic statistical analyses for technical support of product line.
  • Conduct literature reviews and write research summaries related to product line.
  • Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
  • Prepare product Instructions for Use and assist with labeling and labeling changes (including receipt of applicable translations).
  • Generate final clinical study reports.
  • Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
  • Evaluate and report on adverse events, complaints, and failures associated with the product line.
  • Attend surgical congresses as necessary.
  • Complete necessary product Clinical Evaluation Reports and/or any other reports necessary to support regulatory submissions.
  • Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) marketing literature.
  • Responsible for site recruitment/selection, investigator meetings, and management of clinical study sites.
  • Ensure that clinical trials are conducted in accordance with applicable standards and regulations.
  • Oversee project budgets, budget change forms, accruals, and monthly reports.
  • Other assigned responsibilities (including previously identified tasks being performed at a higher level than one's current title)

QUALIFICATIONS

  • Minimum 4-6 years experience, within the medical/biomedical industry.
  • Experience managing a clinical project team and Phase III clinical studies.
  • BS or MS degree in biological science, epidemiology, engineering, statistics, or other science-related field.
  • CRA certification or certification eligible.
  • Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).