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Title:Director, Clinical Programming
Salary:Open
Experience:9+
Location:CA - Foster City

Description:
Work collaboratively with Clinical Data Associate, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.

Responsibilities:
  • Responsible for managing a highly effective team of Clinical Programmers supporting clinical data management.
  • Ensure completeness, correctness and consistency of clinical data and data structure.
  • Providing leadership in the area of systems, processes and tools for clinical data collection and management;
  • Ability to design and use all available vehicles for effective scientific communication within and outside the company;
  • Ability to anticipate obstacles and difficulties of clients and act upon demands in order to meet team goals;
  • Ability to utilize appropriate clinical programming resources to solve technical issues; supervising, training, and mentoring staff;
  • Participating on departmental management team, providing strategic direction for clinical programming
  • Able to work on unusually complex technical problems and provide solutions that are highly innovative and cost conscious,
  • Able to make effective decisions where information is limited or solutions may produce unpleasant consequences in the short term, negotiates timelines given constraints.
  • Ability to consider the implications of conducting international studies,
  • Ability to lead initiatives to gather, organize, and analyze interim clinical data from various sources,
  • Ability to examine issues from various perspectives as well as the ability to determine and apply appropriate clinical programming concepts when addressing clinical programming solutions.

Requirements:
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions.
  • A team player with an entrepreneurial spirit, a strong and assertive communicator in the company of other such people
  • Someone with sound judgment and flexibility with a dynamic personality will make the greatest contribution in this role.
  • Requires a Master’s degree in a Biomedical Science, clinical background/experience desirable, with more than 9 years working experiences, or Bachelor’s with 12 or more years working experiences in SAS programming in a CRO or bio/pharmaceutical setting, including experience managing people.
  • Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
  • Ensure clinical programming work is completed in a consistent manner and validated according to departmental practices.
  • Knowledge of relational database design, FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is a plus.
  • Demonstrates excellent communication, problem solving and people/project leadership skills.

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