Clinical Trials Transparency Manager
The Clinical Trial Transparency Manager (CTTM) will be responsible for accurate and timely national and international posting of all clinical trial information, both pre- and mid-study information, and post-study results. In this roll, the CTTM will develop in-depth knowledge of the posting requirements for all portals in which Vettex participates. The CTTM will work with cross functional departments e.g., Clinical Development (including Biometrics and Data Analysis, Clinical Operations, and Regulatory Affairs), Quality Management and Control, Corporate Compliance, and specific colleagues to ensure timely and accurate information is entered into the required portals. Recognizing that performance in this role will be cyclical and tied to clinical trial start-up and completion timing, the CTTM will also be assigned other cross-functional project management roles specific to Clinical Business Operations (CDE) to ensure he or she has a job that is equal to a full-time equivalent. These assignments will be in areas that help inform and develop the core responsibility of clinical trial posting.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
The responsibly for all trial posting will require the incumbent to have advanced and well-practiced project management skills and methods necessary to stay current with all ongoing studies at Vertex in order to create timely and accurate initial and updated postings. The incumbent will rely heavily on many cross functional colleagues to obtain the requisite information and therefore will require adept skills in peer-management and interpersonal communication. To be successful, the incumbent will need to be a consummate "team player" and be able to stay focused and current on multiple, but associated assignments.
- Reports to Global Medicines Development and Affairs (GMDA) through CDE.
- Starting from an initial foundational understanding of posting requirements, build a detailed understanding of the particular nuances to information posting associated with the different p01tals, e.g., Clinical Trials.gov, EudraCT.
- Works directly with Study Execution Teams (SETs) and pertinent department heads to obtain accurate and timely information for posting, e.g., research site information, study profile information, study time lines.
- Works directly with Biometrics to obtain pertinent study data for posting.
- When required, seeks formal and time-based cross-functional review of clinical trial postings before these are entered into the public forum.
- Follows all quality control practices prior to any information posting and ensures completion of these steps within the timeline set forth for any posting deadline.
- Liaises with Regulatory Affairs to ensure coordination of information posting visa vis other Regulatory Affairs information communication strategies and operations.
- Create and maintain a library of time-stamped, per study posting entries.
- Perform periodic, formal quality control reviews of postings vs. corporate time lines and development plans to identify and rectify process and communication gaps. Creates and sets forth improvements in posting processes as necessary.
- Create clinical trial posting practices and policies along with key stakeholders that are scalable and flexible to address the emerging international trial transparency requirements.
- Works directly with the head of CDE on non-posting projects as these are assigned.
- Additional assignments as identified.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
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.