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 the management of, as well as the delegation of responsibility for ongoing management and oversight of clinical trial study projects as assigned. The Project Manager will direct activities to meet our client’s specifications, ensuring quality deliverables are on time and within budget.
Essential Duties and Responsibilities
• Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.
• Independently leads medium to high complexity, multi-regional (>2) global projects which may include oversight and leadership of supporting co-PMs and regional LabConnect PMs.
• Participates in the handover process between Business Development (BD) and the Project Set-Up Team and in the training process of internal staff and handover from Set-Up 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.
• Maintenance of project Dashboard including risk register (portions may be delegated)
• 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.
• 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.
• Interfaces with Laboratory Services, Site Support Services, Project Coordinators, Digital Tracking, Business Development, Finance, Project Management, external Project Management, Specimen Management, Information Technology and Data Management personnel to ensure support and deliverables are met as outlined in specification documents and contracts.
• 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 Experience
• Bachelor's degree (B.A./B.S.) from four-year college or university; and two years central laboratory project management experience.
• Associates degree (A.A/A.S) will be considered if combined with 3+ years of central laboratory project management experience.
• Certification as an ASCP Medical Technologist and/or Registered Nurse is beneficial, but not required.

Skills and Ability
• Experienced in customer service and possess excellent organization and interpersonal, communication and critical thinking skills.
• Must be adept at stress management.
• Strong language skills, including the ability to read and interpret complex business, technical, and regulatory materials; write clear reports and procedures; and effectively present information to stakeholders.
• Proficient in performing calculations, managing budgets, and applying mathematical concepts to areas such as clinical trial budgeting and metrics analysis.
• Skilled in solving practical problems, interpreting diverse types of instructions, and navigating situations with limited standardization.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint) with additional experience in SharePoint, Salesforce, and Microsoft Visio considered a plus.

Supervisory Responsibilities: None
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