Sr. Project Manager

Thousand Oaks, California 91320 | Contract

Post Date: 01/11/2016 Job ID: 1272 Industry: Project Management

  • Some drug development experience, either Clinical Operations, Data Management.
  • Preferred experience with clinical systems including IXRS (most important) and eCOA or other clinical systems
  • Project management experience strongly preferred



Job Summary:


The position will work with a cross functional team of internal stakeholders (including Clinical, Biostatistical and Supply Chain representatives) and external stakeholders (IVRS provider representatives) to support the design, implementation and maintenance of outsourced electronic solutions to support a clinical trial. The individual within this role will provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines


Key Responsibilities include:

• Lead study level system requirements meetings with internal and external clients • Design and oversee the development of study specific technical documents • Document possible risk and implement mitigation plans • Manage project related timelines and associated activities • Identify and track study-related technical issues to resolution • Provide a supportive framework for continuous process and quality improvements

Basic Requirements:


Doctorate Degree OR Master's Degree & 3 years of Clinical experience OR Bachelor's Degree & 5 years of Clinical experience


Preferred Requirements:


• Bachelor’s Degree in life science, computer science, engineering, business or related discipline

• 4 or more years of experience in clinical operations, clinical development or clinical quality assurance

 • Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred

 • Knowledgeable in Good Clinical Practices, and FDA regulations necessary

 • Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills

• Candidates must have previous vendor/client management experience

• Excellent time management and organization skills required

• Must have sound problem resolution, judgment, and decision-making abilities

• Must be able to work well in a team-based environment with minimal supervision

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