USA - Clinical Operations Manager

We are seeking a highly motivated Project Coordinator to manage the DMPK operational logistics of our early-stage drug discovery assays, pharmacokinetics studies, and compound management processes. This role is crucial for maintaining efficient workflows between internal research teams and external Contract Research Organizations (CROs), ensuring smooth execution of experiments, data tracking, and financial administration during the contract term.

Key Accountabilities and Responsibilities

The primary responsibilities for this contract role are:
* Assay Request System (ARS) Management: manage the end-to-end process for incoming assay requests using the internal ARS platform. Create and track study orders, troubleshoot system issues, and register new assay codes as needed. Facilitate the onboarding process for new CROs within the ARS ecosystem.
* Compound Management and Logistics: Oversee compound sourcing and logistics, including availability checks, internal ordering, and external shipping coordination. Manage compound plating, tracking, and inventory updates. Coordinate seamlessly with internal compound management teams, external CROs, and third-party vendors to ensure timely delivery and accurate handling of research materials. Onsite presence may be required for some shipments.
* Data Management and Integrity: Ensure the timely and accurate upload of assay data into our primary data repository (e.g., D360, similar internal system). Maintain rigorous documentation and ensure all relevant information within the ARS is current and accurate.
* Contracts, Financials, and Vendor Management: Establish, review, and maintain annual Statements of Work (SOWs) and rate cards with key vendors. Monitor Purchase Orders (POs), manage change orders efficiently, and review CRO cost summaries for accuracy and compliance.
* Study Support Coordination: Manage the quotation process for new studies and draft study-specific SOWs. Obtain necessary internal tracking numbers (e.g., G-TRAKS) and set up new studies on external collaboration platforms (e.g., Science Exchange).
* CRO Communications and Relationship Management: Serve as the primary liaison for day-to-day ARS communications with external partners. Coordinate subject matter expert (SME) and CRO meetings and support the logistical implementation of new assay protocols at vendor sites.
* Data Analytics and Metrics Reporting: Track and analyze assay submissions, execution metrics (turnaround times, success rates) across both internal teams (TAS) and external CROs. Perform spend analytics and provide comprehensive monthly reports and key performance indicator (KPI) dashboards to management.

Qualifications and Desired Experience
* Education: Bachelor s degree (BS) in Biology, Chemistry, or another related scientific field is highly recommended.
* Experience: 4-7 years of experience in biotech, pharmaceuticals, or a research operations role (Intermediate Level), specifically within assay operations, compound management, or vendor management. Note: 0-3 years is suitable for an Associate level; 8+ years is suitable for a Senior level hire.
* Attributes: Excellent organizational skills, meticulous attention to detail, strong problem-solving abilities, and superior communication skills. Proven ability to operate independently and manage multiple projects and priorities effectively in a dynamic environment.