Clinical Operations Manager, Senior

Provides strategic guidance, oversight, and effective delivery for clinical programs in area of focus in partnership with cross-functional key stakeholders involved in clinical development, including Biometrics, Clinical Science, Medical Affairs, and Lifecycle teams. Actively participates on cross-functional project teams responsible for the development and commercialization of products developed by RMS, such as, clinical software, instrument platforms, and assays. Foster cross functional relationships to create a cooperative work environment in support of corporate goals. Ensures alignment across studies and lifecycle teams with current regulatory expectations.

ESSENTIAL RESPONSIBILITIES:

• Independently 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.
• Responsible for the implementation and maintenance of the clinical trial-related policies, as well as processes and procedures related to the Design Control requirements.
• Provides input to budgets. Identifies opportunities to reduce costs. May manage portions of larger area(s) budget.
• Accountable for ensuring that budgets and schedules are met.
• 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.
• 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 the trial budgets and timelines.
• Manages relationships with international opinion leaders, investigators and key customers.
• Manages internal and external resources to support scheduled studies.
• Ensures direct reports are in compliance with regulations, SOPs and protocols.
• Oversees complex and significant studies
• Represents the department at cross functional project teams and Business Unit level
• Implements of global study support strategies and initiatives
• 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 independently and is highly autonomous.
• Serves as subject matter expert with external resources and contacts at various management levelsconcerning operations or scheduling of specific phases of projects.

MINIMUM QUALIFICATIONS:
Formal Training/Education:

• Bachelor degree in scientific discipline or related field required.

Experience:

• 10+ years of experience in clinical trials is required
• 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.

TRAVEL REQUIREMENTS:
Travel Requirement: Approximately 20% of time travel domestic and/or international.