Senior Manager, Clinical Monitoring (remote) Job at Vertex Pharmaceuticals
Job Description
General Summary:
The Clinical Monitoring Senior Manager (Lead Clinical Research Associate) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on single or multiple region clinical trials of moderate to high complexity or managing regional-based activities on large global trials across a range of study phases and therapeutic areas. The role is also responsible for contributing to Clinical Monitoring department initiatives, often as a technical resource.
Key Duties and Responsibilities:
- Contributes to the study level monitoring strategy, overseeing development and execution of the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials
- Responsible for training the CRAs on the study and ensuring study training compliance is maintained
- Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
- Identifies monitoring risks and implements contingency plans with minimal supervision
- Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc…) to ensure the CRAs are informed and managing their site’s data with quality and integrity
- Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
- Conducts regular meetings with their CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
- Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
- Represents Clinical Monitoring department as a technical resource in cross-functional initiatives or process improvement efforts (e.g. SOP and WI updates) as assigned by management
- Mentors more junior or newly hired clinical monitoring staff
Knowledge and Skills:
- Ability to travel up to 30% of the time
- Fundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCP
- Strong knowledge of clinical trial systems, e.g. electronic case report forms, electronic Trial Master File, and Clinical Trial Management System
- Excellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environment
- Proven effectiveness as a team leader, including mentoring junior CRAs
- Outstanding interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity
- Demonstration of successful execution of programs in a fast-paced environment managing multiple priorities
Education and Experience:
- Bachelors degree or equivalent degree required, or relevant experience
- Typically requires 5 years Clinical Research experience, with at least 3 years of experience in clinical site monitoring
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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