Senior 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. 

Job Summary

The Senior Study Set Up Manager is responsible for setup of projects (moderate to high complexity) and for internal staff training.  Working closely with the Sr. Manager/Manager and other Client Services staff, the Senior Study Set Up Manager will direct activities to meet our client’s specifications, ensuring quality deliverables. S/he will liaise with other departments to ensure set-up 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 the Study Set Up team to assist in study setup.
• Assists in interviewing and hiring of Study Set Up staff.
• Assists Managers/Directors and/or departmental managers with process improvement initiatives.
• Assist Managers with obtaining, developing and reporting departmental metrics.
• Liaise with directors and other manager/supervisors on new processes or system developments and to remain current on changes affecting operations.
• Translates client requirements into actions for problem solving, issue resolution, or to provide requested information; often requires a creative approach to serving client needs while adhering to internal process and standards.
• Mentors and trains new team members.
• Provides backup to team members during study setup for clinical trial projects.
• Creates or assists with development or amendment 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 amendment 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 set up phases.
• Trains or assists with project-specific training of internal staff.
• Assures meeting minutes are captured.
• Liaise with Commercial Finance to ensure all applicable Operational Specification Document changes have been applied to client budgets.
• 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.
• Creates or oversees development of training materials for external kick-off meetings as applicable.
• As assigned, may initiate medium and high complexity projects.
• Authorizes study setup documents.
• Performs other related duties and tasks as necessary or as assigned.
• Ability to comprehend project specific budgets.

Education and Qualifications

Bachelor's degree (B.A./B.S.) from four-year college or university; and three to four years central laboratory experience or related clinical experience, including at least 2 years experience as a Project Manager. Or an Associates degree (A.S) and 5-6 years central laboratory or related clinical experience, including at least 3 years experience set-up related experience and/or Project Management experience. Must be experienced in customer service and possess excellent organization and interpersonal, communication and problem solving skills. 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. Excellent organization, communication, multitasking skills.

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.

Certificates and Licenses

None required.

Language Ability

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry related to various scientific calculations required for clinical trials.

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, an individual must have a working knowledge of Microsoft Office applications including word processing, spreadsheets, PowerPoint, and MS project.

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 and talk or 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 50 pounds.  Specific vision abilities required by this job include close vision and ability to adjust focus.