Study Set Up Manager - Project Initiation

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. 

Summary

The Study Set Up Manager is responsible for the setup of projects and for internal staff training. S/he will develop or amend the Operational Specification Documents (OSD) to define client expectations and liaise with other departments to ensure setup processes are correct and efficient for each department as well as to service client needs.  The following duties are normal for this position; however, they are not to be construed as exclusive or all-inclusive.  Other duties may be required and assigned.

Responsibilities

• Works closely with Study Set Up team to assist in study setup, and train/develop towards advancement to Sr. Study Set Up Manager position. 
• Provides backup to team members during study setup for clinical trial projects.
• Mentors and trains new team members.
• Creates or assists with the development or amending of Operational Specification Documents to define client requirements.
• Completes or assists with review of IT (LIS) database verifications and assures they are completed prior to specimen receipt and reporting for specific project.

• Assists in maintaining Project Milestones in Salesforce.

• Completes or assists in uploading finalized documents in SharePoint.
• Creates or assists with development or amending of customized test requisitions, laboratory manuals, and specifications for collection kits.
• Liaise with colleagues to ensure setup related tasks required have been performed.
• Schedules or assists in scheduling meetings during study initiation phase.
• Trains or assists with project-specific training of internal staff.
• Assures meeting minutes are captured.
• Primary or secondary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to.
• As needed, interfaces with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem solving.
• Liaise with Commercial Finance to ensure all applicable Operational Specification Document changes have been applied to client budgets.
• Creates or oversees development of training materials for external kick-off meetings as applicable.
• As assigned, may initiate low, medium, and high complexity projects.
• Authorizes study setup documents.
• Performs other related duties and tasks as necessary or as assigned.

Education and Qualifications
Bachelor's degree (B.A./B.S.) with 3-5 years’ customer clinical research industry experience, 3 years set-up related experience and/or Project Management experience. Excellent organization, communication, multitasking skills. Experience in contract research and/or research setting preferred. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Clinical Research, Central Lab, and/or Project Management experience outside of LabConnect will be considered.

Required Skills

• Excellent attention to detail, strong planning and problem-solving skills. 
• Excellent organizational and time management skills.
• Excellent listening and verbal comprehension skills, including ability to translate client needs to team members.
• Ability to make well-thought-out decisions and adapt to changing environments and requirements.
• Self-motivating and ability to work well independently as well as using a collaborative team approach.
• Ability to adhere to established timelines, processes and procedures.
• Proficient in Microsoft Word, Excel, and database software.
• Customer service/client relationship management skills.
• Ability to comprehend project specific budgets.

Certificates and Licenses

None required.

Language Ability

Ability to read, analyze, and interpret general business periodicals, professional journals, or technical procedures.  Ability to write business correspondence and procedure manuals.  Ability to effectively present information and respond to questions from managers and clients.

Math Ability                                                        

Ability to perform calculations and manage budgets.  Ability to apply mathematical concepts to budget management for clinical trials and metrics analysis.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

To perform this job successfully, the individual must have a working knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint.  SharePoint and Microsoft Visio experience a plus.

Supervisory Responsibilities

Responsibilities may include training, and mentoring employees; planning, assigning, and directing work.

Work Environment

The noise level in the work environment is usually moderate.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and hear.  The employee is occasionally required to stand; walk and reach with hands and arms.  The employee must occasionally lift and/or move up to 30 pounds.  Specific vision abilities required by this job include close vision and ability to adjust focus.