Clinical Project Manager
The Clinical Project Manager acting as the Clinical Operations Study Lead (COSL) is responsible independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed.
- Responsible for developing and managing approved trial budget(s).
- Develops and oversees study operational plan(s).
- Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
- Assists with protocol design and strategy and medical issue resolution.
- Prticipates in study data review and assists with patient narrative writing and other data review activities as assigned.
- Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports.
- Proactively identifies project risks and resolves with some supervision.
- Participates in the selection of Investigators and vendors.
- May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel.
- Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team.
- Performs other duties as assigned.
- Bachelors Degree
- Six years of project management experience with clinical studies in a sponsor setting.
- Masters Degree
- Strong study management track record showing clear proficiency in clinical project management skills.
- Solid vendor management skills.
- Broad understanding of operations including those in related development functions.
- Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development.
- Demonstrates ability to effectively interface with key medical personnel at clinical site(s).
- Demonstrates ability to lead multi-disciplinary teams.
- Possesses excellent written and oral communications skills.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, 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, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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