- 7+ years of experience in clinical trials is required, 9+ preferred
- Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
Knowledge, Skills, and Abilities
- Demonstrated ability to work collaboratively across all levels of an organization and to lead influentially
- Ability to operate and lead efficiently in a heavily matrixed and multi-site organizational structure.
- Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
- Excellent knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)
- Ability to initiate and effectively lead change efforts, and ensure people accountability.
- Strong communication, presentation, and interpersonal skills and ability to build close working relationships across the organization and with alliance partners.
- 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 RMS and the Diagnostics 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.
MINIMUM QUALIFICATIONS: Formal Training/Education:
- Bachelor degree in scientific discipline or related field required.