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 [email protected] .
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