Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
- Responsible for the successful planning, implementation and execution of clinical study (ies) to verify and validate new clinical software, instrument platforms, assays and biomarkers developed by the Company
- Functionally responsible for all clinical monitoring activities throughout the duration of each clinical trial.
- Assures clear external/internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth.
- Plans and executes clinical trial programs for assigned area of focus for registrational trials and/or non-registrational and/or research studies for US or outside US with moderate supervision.
- Responsible for the implementation and maintenance of the clinical trial-related policies, as well as processes and procedures related to the Design Control requirements.
- Works with the project manager to define budgets and timelines for each study and accountable for delivery of study milestones.
- Provide technical expertise to staff for the development of clinical trial documents and records (protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct with moderate supervision.
- Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence.
- Acts as liaison with the Clinical and Medical groups within the division and other partners to identify and implement collaborative studies, regulatory activities, and other programs.
- Responsible for adhering to regulations, guidelines and departmental standard operating procedures.
- Manages relationships with international opinion leaders, investigators and key customers.
- Manages internal and external resources to support scheduled studies.
- Oversees complex and significant studies with moderate supervision.
- Represents the department at cross functional project teams and Business Unit level.
- Implements of global study support strategies and initiatives with moderate supervision.
- Regularly interacts with executive management on work of area(s) that impacts larger organizational goals.
- Responsible for establishing plans for area with input from more senior management.
- Fully accountable for the results and achievements of the area.
- Works with moderate supervision and autonomy.
- Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.