Study Designer

CTI Clinical Trial and Consulting Services•Covington, KY

About The Position

The Study Designer will translate documented customer expectations into seamless services within the CTI Laboratory Services database. This role requires leveraging technical, therapeutic area, client, and CTI Laboratory Services process knowledge to conduct comprehensive protocol reviews. The Study Designer will liaise with internal departments and the Laboratory Project Manager to understand CTI Laboratory Services capabilities and assess the feasibility of requests to meet client needs related to study design. This position involves managing and solving complex technical changes, issues, and concerns with minimal guidance, while displaying strong interpersonal and communication skills to build internal relationships and ensure high-quality study design. The role is responsible for delivering quality technical services, ensuring consistent use of SOPs, and performing self-reviews and reviews for other Study Designers. The Study Designer must be able to act efficiently in an environment with dynamic timelines and priorities, demonstrating self-organization and the ability to manage conflicting priorities. They will lead and participate in functional meetings, provide input, and keep processes up-to-date. Additionally, the Study Designer will act as a Technical Expert by participating in process improvement initiatives and performing other duties as assigned.

Requirements

Associate degree (or equivalent) with at least 2 years of relevant central laboratory experience or 4 years relevant central laboratory experience
Strong planning, organizational and problem solving skills
Strong verbal and written communication skills
Effective negotiator in complex and uncommon situations
Strong computing skills, especially databases
Great communicator with strong written and verbal fluency in English
Detail oriented to drive tasks to completion
Ability to work well in a rapid-paced startup environment
Ability to work well in a group

Responsibilities

Translate all documented customer expectations in the CTI Laboratory Services database to provide seamless services
Leverage technical, therapeutic area, client and CTI Laboratory Services process knowledge to provide a comprehensive review of the protocol
Liaise with internal departments along with the Laboratory Project Manager to understand CTI Laboratory Services capabilities and assess the feasibility of requests to meet client needs related to study design
Manage and solve technical changes, issues and concerns of high complexity work with little to no guidance
Displays strong interpersonal and communication skills that will build strong internal relationships to ensure high quality study design
Responsible for delivering quality technical services related to assigned clients. Ensure the consistent use of SOPs
Performs quality self-review in addition to review for other Study Designers when requested Able to act efficiently in an environment with dynamic timelines and priorities
Displays appropriate self-organization and ability to manage conflicting priorities
Leads and participates in functional meetings and provides input, keeping processes up to date
Act as a Technical Expert by participating in process improvement initiatives
Other duties as assigned