Study Design Lead

Study Design Lead

Support role which works with internal teams to review, update, and assist with the completion of study startup documents with oversight from a Study Design Lead. Assists with administrative tasks.

Essential functions of the job include but are not limited to:

• Works on problems of limited scope; follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained
• Learns to use professional concepts. Applies company policies and procedures to resolve routine issues
• Contacts are solely internal to the company on routine matters. Builds productive internal working relationships
• Normally receives detailed instructions on all work
• Understand and complete revision requests accurately and work closely with internal teams to execute them efficiently
• Work with internal teams to successfully coordinate the completion of design documents for lab services
• Ensure all customer requirements are documented appropriately
• Ensure that work product complies with design and performance standards, regulatory environment and customer expectations; enforce standards applicable to each step in project execution
• Assist in development of the Project Specifications Document, with stakeholder input, to document requirements for Lab Manual, Kit Design, Kit Components, Couriers, Sample Management, Sample Processing, and Lab Database; assist in development of the Lab Manual and Project Operating Procedure for Precision Labs
• Assist with the review and update of all documentation associated with project(s) to approvable status
• Build strong relationships to ensure high quality study design; collaborate with key stakeholders from PM, Clinical, and Lab on study design
• Coordinate with other project staff to identify and consolidate support processes
• Monitor assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. Completes additional tasks needed in support of project, customer and departmental objectives
• Complete other responsibilities, as assigned

Qualifications:

Minimum Required:

Bachelor's degree in a life science or related field (e.g., engineering)

Other Required:

• Excellent computer skills and experience with MS Office/MS 365 applications
• Excellent communication, interpersonal, organizational, and multi-tasking skills; skilled emotional intelligence
• Able to work in front of a computer for long hours at a time
• Strong understanding of technical writing and data analysis
• Strong critical thinking, analytical, and problem-solving skills
• Exceptional research and reporting skills; ability to convert research to valuable insights
• Extended work hours may be necessary in order to meet business demands
• Strong presentation skills
• Excellent use of judgment and discretion
• Able to read, write, and fluently speak and comprehend the English language
• Proven track record of being a team player and leader, willing to interact proactively and productively