Study Design Lead

Position Summary:

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

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at

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