Project Manager, Clinical Research

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America

Lab Connect 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.

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.

• 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 Lab Connect at client and/or investigator meetings.
• Performs other related duties and tasks as necessary or as assigned.

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

Business fluent in English.

Knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint. SharePoint and Microsoft Project experience a plus.

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

Ability to travel up to 20% required.

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

• 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
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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…