Project Manager

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 Project Manager, Project Management, is responsible for oversight of assigned clinical studies. S/he will participate in development of Statements of Work (SOW) to define client expectations, and will perform duties associated with day-to-day oversight of ongoing clinical trial study projects, throughout the life of the trial to ensure quality deliverables on time and within budget.

Responsibilities

• Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.
• Participates in the handover process between Business Development (BD) and the Project Initiation Services team (PIS), and in the training process of internal staff and handover from PIS to the PM.
• Primary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to.
• Serves as first point of contact for management issues related to clinical trials.
• Works closely and in coordination with clinical laboratory management and directors in support of clinical trials.
• Review of reports and documents, including enrollment logs, pending test reports, reporting from other laboratories, issue logs, shipping manifests, and other documents that assist with study oversight.
• As needed, interfaces with laboratory(ies), BD, Operations, and Data Management.
• Liaise with Project Coordinators to ensure study-related tasks have been performed, and with the assigned data manager to ensure data is delivered on time per the SOW.
• Review and analyze operational, quality, and performance related metrics to assess the success of study oversight activities.
• Liaise with managers/supervisors in other departments to stay informed of operational changes.
• Collaborate with project managers in partner laboratories to provide a global overview of study management.
• Coordinate requests for shipment of stored samples as directed in the SOW.
• Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices.
• Creates training materials for investigator meetings as applicable.
• Represents LabConnect at client and/or investigator meetings.
• Performs other related duties and tasks as necessary or as assigned.
  
  

Education And Qualifications

Associate’s degree, preferably in a laboratory science, or equivalent combination of education and experience. Strongly preferred: Medical Technology or MLT degree with 3+ years related laboratory experience, or experience in the clinical trial industry in a project oversight role. Excellent organization, communication, multitasking and interpersonal skills. Customer service/client relationship management skills

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 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.

Certificates and Licenses

Certification as an ASCP Medical Technologist and/or Registered Nurse is preferred.

Supervisory Responsibilities

Some supervision of employees in the Early Development/Scientific Operations department may be required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, training, and mentoring employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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.

Join our team and discover how your work can impact patients' lives around the world!

Some of the Perks our LabConnectors Love:

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!
  
  

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/

If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected] or call +1 (423) 722-3155.