Clinical Trial Transparency, Senior Manager
The Clinical Trial Data Transparency (CTDT) Senior Manager is responsible for the operational execution of Vertex’s clinical trial disclosure activities, including protocol registration and results postings, on local, national or regional clinical trial registries. The CTDT Senior Manager will partner closely with functional groups and other internal stakeholders to ensure that trial disclosures adhere to internal processes/strategy and comply with all applicable laws, regulations, policies and registry requirements. The role will also contribute to the development and maintenance of processes and standards that support Vertex compliance with current or future global clinical trial disclosure requirements.
Key Duties and Responsibilities:
- Plans and executes clinical trial registrations, results postings, and maintenance of trial registry records, according to all applicable laws, regulatory requirements and policies
- Consults with internal stakeholders and functions to ensure that clinical trial registration and results postings are accurate and adhere to internal policy /strategy and registry requirements
- Conducts quality reviews of clinical trial disclosure deliverables, tracks compliance and compiles metrics for all disclosure-related activities
- Acts as a clinical trial disclosure liaison to study teams in communicating Vertex disclosure policies, processes, and system requirements to ensure compliance
- Supports and/or develops relevant training and process-related documents, including internal guidance, standard operating procedures (SOPs) and work instructions (WIs)
- Acts as the coordinator for external data sharing requests and clinical trial disclosure strategy meetings, including drafting of responses, agendas and meeting minutes
- Works with GIS/GCO and other functions to implement technology solutions related to clinical trial disclosures
- Works with vendors providing trial disclosure services to Vertex
Knowledge and Skills:
- Working knowledge of legal/regulatory requirements and guidelines relating to clinical trial disclosures
- Good understanding of the clinical development process, including clinical trial design, operations and results analysis
- Strong organizational, interpersonal and communication skills for effective communication of information in complex situations
- Demonstrated analytical skills and ability to interpret scientific content
- Ability to work in a team environment and across all levels of the organization
- Ability to multitask and prioritize multiple projects under evolving timelines
- Competent in Microsoft Office (Word, Excel, PowerPoint) and Outlook; experience with Adobe Acrobat
- Experience working in a clinical trial transparency / disclosure, clinical trial operations, medical writing, regulatory affairs or related environment
Education and Experience:
- Bachelor's degree in a scientific discipline, or other relevant discipline
- Typically requires 4 years of experience in pharmaceutical industry and/or clinical research experience, or the equivalent combination of education and experience
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.