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.

Job Summary

The Project Manager is responsible for oversight of assigned clinical studies. The Project Manager 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.
• Monitors scope of services and proactively initiates scope revision and change order process.
• 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.
• Identifies and monitors potential risks and proactively works on mitigations
• 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, Technical Affairs, Vendor Management, 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

Scientific degree, preferably in a laboratory or life science, or equivalent combination of education and experience. Strongly preferred : Medical Technology or MLT / MTL 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

Business fluent in English.

Computer Skills

Knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint.

SharePoint and Microsoft Project experience a plus.

Supervisory Responsibilities

Some supervision of employees in the Early Development / Scientific Operations department may be required.

Required Travel

Ability to travel up to 20% required.

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

Some of the Perks our LabConnectors Love :

In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication.

We are proud to be an Equal 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.

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). For this job posting, all hiring decisions are made with meaningful human involvement and consideration. In this context, no applicant is subject to a decision based solely on automated processing within the meaning of Article 22 of the 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 talent@labconnect.com or call +1 (423) 722-3155.