JOB SUMMARY: The Lead Clinical Trial Associate Lead (LCTA) will support the project team by performing a variety of physical and administrative tasks that aid in the execution of the clinical trial. Areas include (but are not limited to): managing, handling and distributing Clinical Trial Supplies and maintenance of tracking information, updating and maintaining information within clinical systems, creating and maintaining Trial Master Files (TMF - paper and electronic) including periodic review for accuracy and completeness, preparing and handling documentation and reports;u00a0track and manage Case Report Forms (CRFs), queries and clinical data flow. The LCTA provide supervisory support of other CTAu2019s. DISTINGUISHING CHARACTERISTICS: This is the third of a three (3) job series with increasing levels of responsibilities, expertise and experience. The Lead CTA is to be a Subject Matter Expert across the essential responsibilities / logistics functions to the rest of the organization and supervises other CTAu2019s to deliver on project tasks. ESSENTIAL RESPONSIBILITIES: - Oversee the day-to-day activities within the Logistics function and supervise other CTAu2019s. - Works closely with the Director or Manager of the Logistics Function to ensure training of new CTAu2019s and may represent the function at meetings within and outside of Clinical Operations and Biometrics. - Materials (supplies, binders, labels, etc.): Work with study teams to identify specifications and develop study related materials to those specifications working under minimal oversight. Prints labels for all types of materials. - Receiving: Receives, inspects and inventories Clinical Trial Materials (binders, labels, kits, reagents, consumables) insuring appropriate quality, quantities and storage conditions (warehouse, coolers, freezers, etc.), completing relevant documentation as necessary, establishing electronic inventory records, and communicating with Clinical Teams. - Material Management: Maintains electronic and physical inventories of Clinical Trial Materials, relabels marketed products for investigational and/or research use as necessary, tracks expiration dates. - Picking / Packing / Shipping: Follows moderate to complex instructions from Clinical Team to fill shipping requests of Clinical Trial Supplies and/or Samples insuring accuracy of items and quantities, appropriate packing materials and shipping conditions (e.g., frozen, refrigerated and ambient), as well as shipping instructions to insure compliance with all DOT, IATA, and local and federal regulations. - Creates, maintains and audits Trial Master Files (TMF - paper and electronic), including interacting with internal and external study team members and investigator staff for collecting and managing related study documents. - Establish good working relationships across all Life Cycles and Facilities groups to effectively deliver work objectives. - Accurately and effectively communicate services / capabilities, needs, issues, material inventories, and project status with all necessary groups and individuals (Manager / Supervisor, Study Teams, Facilities, etc.). - Performs additional duties as requested by manager or designee. Roche is an equal opportunity employer. Research & Development, Research & Development > Clinical Development Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individualu2019s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.