Technical Program 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. The Technical Program Manager will be responsible for providing program management and oversight to a biopharmaceutical client tasked with managing a portfolio of specialized project deliverables and programs spanning diagnostics and novel endpoints. He/she will provide project management and technical support to cross-functional teams and stakeholders, developing project workstreams, conducting risk management, timeline and budget oversight, and managing contracts. The Technical Program Manager must have the ability to effectively manage and monitor the progress and deliverables across multiple functional areas within the project, coordinating the efforts of each cross-functional team within the program toward product approval and deployment. The incumbent will also be responsible for managing operational documentation and maintaining shared sites, folders, dashboards, budget trackers and critical regulatory and decision-making documents.

• *Responsibilities Include:**

• Provide program management and oversight, including:

• Preparing the agenda and leading the weekly cross-functional team
• Capture key decisions and action items along with rationale and reasoning
• Follow up on action items with responsible parties to ascertain timely resolution
• Proactively reach to stakeholders offline and schedule smaller group meetings as needed
• Generate and maintain PowerPoint presentations for key meetings
• Develop and maintain shared sites/folders/dashboards/budget trackers and key regulatory and decision-making documents
• Oversee all program activities, including identifying and mitigating risks, developing project workstreams, and managing ongoing contracting efforts and processes
• Manage the efforts to develop precision medicine and digital pathology solutions by organizing and coordinating the cross-functional efforts and collaboration towards product approval and deployment
• *Required Knowledge and Skills:**

• A thorough understanding of bioanalytical methods with a focus on pathology, biomarkers, precision medicine, oncology, bioinformatics

• Experience in bioanalytical method development, validation, formal technical transfer of methods and method performance monitoring.
• Strong assay and process troubleshooting skills.
• Strong communication skills.
• Cross-functional and cross-site team management experience.
• CRO performance and relationship management experience.
• Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)
• Proficiency in technical writing and document control.
• Common and specialized computer software application proficiency and adaptability.
• *Essential Duties and Responsibilities:**

• Provide project management oversight and subject matter expertise in GLP bioanalytical testing, method development, validation and technical transfer to ensure scientific integrity and adherence to the protocol/plan/contracts and applicable regulations.

• Interact with U.S. and international CROs and effectively communicate updates, reports and recommendations to management teams.
• Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines.
• Provide technical support to troubleshoot specific issues that impact the project.
• Manage Supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.
• Recommend and implement new processes and procedures to standardize, simplify and enhance quality and compliance of the department’s operations.
• Expected to participate in the management and control of GLP documentation and records, and contribute to and (co) author scientific and/or operational documents such as SOPs, validation protocols and reports, transfer protocols and reports, posters, journal publications and other technical reports.
• *Education/Experience:**

• M.S., Life Sciences or related fie Apply tot his job Apply To this Job