Study Design Lead

11 minutes ago
Full-time
Entry Level
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Review, update, and assist with completion of study startup documents.
  • Execute revision requests accurately and efficiently with internal teams.
  • Coordinate completion of design documents for lab services.
  • Document customer requirements appropriately.
  • Ensure work product complies with design standards, performance standards, regulatory requirements, and customer expectations.
  • Assist in developing the Project Specifications Document for lab-related requirements.
  • Assist in developing the Lab Manual and Project Operating Procedure for Precision Labs.
  • Review and update project documentation to approvable status.
  • Collaborate with stakeholders from PM, Clinical, and Lab teams on study design.
  • Coordinate with project staff to identify and consolidate support processes.
  • Monitor assignments, prioritize work, and adjust schedules to meet deadlines.
  • Complete additional responsibilities as assigned.

Requirements

  • Bachelor's degree in a life science or related field, such as engineering.
  • Excellent computer skills with experience using MS Office/MS 365 applications.
  • Strong communication, interpersonal, organizational, and multitasking skills.
  • Strong understanding of technical writing and data analysis.
  • Strong critical thinking, analytical, and problem-solving skills.
  • Exceptional research and reporting skills with the ability to convert research into insights.
  • Strong presentation skills.
  • Excellent judgment and discretion.
  • Ability to read, write, speak, and comprehend English fluently.
  • Ability to work in front of a computer for long periods.
  • Ability to work extended hours as needed to meet business demands.
  • Proven track record as a team player and leader who interacts proactively and productively.
  • Emotional intelligence is required.
  • Experience in a routine, closely supervised support role is implied by the role level.

Interested in this position?

Apply directly on the company website

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