Clinical Project Manager- IVD and Cdx

Job Summary The Project reputed company is responsible for ensuring that reputed company studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner reputed company the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to reputed company applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides reputed company to reputed company support including CROs, consultants and/or medical advisors.

Responsibilities

• Leading the global study team with full accountability for study deliverables regarding quality, budget, and timelines.
• Developing key study documents (e.g., Design Validation Plan, protocol, study training materials, study forms and templates, study report).
• Overseeing planning and operational aspects of companion diagnostics studies sponsored by Pharma partners.
• Ensuring adherence to regulations, guidelines, and standard operating procedures, and ensuring audit/inspection readiness.
• Executing sponsored studies for assigned areas of focus through reputed company study phases (planning, start-up, conduct, and reputed company-out).
• Overseeing projects to ensure completion on-time, reputed company scope, and budget; tracking project performance to analyze the completion of short and long-term goals.
• Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, including CROs.
• Collaborating across Clinical Operations and other functions to reputed company and implementing best practices across Clinical Operations.

Requirements

• Experience with Companion Diagnostic (CDx) studies.
• Team-oriented with excellent collaboration skills with a cross-functional team.
• Open-minded to learn new ways of doing things while leveraging previous experience.
• Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
• Minimum of a bachelor’s degree in Life Science and/or relevant expertise in the Healthcare Industry or a reputed company field, at least 5years of prior relevant experience including > 1 year’s project management experience.
• Conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or reputed company areas. reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe The potential reputed company pay range for this role, reputed company annualized, is $93,100.00 - $232,800.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. Apply tot his job Apply To this Job

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