The Principal Clinical Trials Manager is responsible for the planning, implementation and conduct of large, complex clinical trials or multiple smaller studies across indications or development compound(s). The Principal Clinical Trials Manager is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables.
Advance those of the Senior Clinical Trials Manager to include the following:
MANAGERIAL AND COMMUNICATIVE SKILLS:
- Able to develop and execute complex study plans in one or more clinical studies with minimal supervision
- Provides oversight and integration activities of all Clinical Operations staff supporting assigned projects
- Able to draft plans for multiple related studies, with oversight
- Develops study budget(s) with oversight
- Attends scientific meetings and builds relationships with Investigators, business partners
- Participates in study data review and interpretation
- Participates in and contributes to publication strategy and content
- Assumes a lead role in the identification process of Investigators or vendors and assures proper prequalification of clinical sites
- Ensures external and internal documentation prepared within the Clinical Operations function is completed in
- May represent Clinical Operations on Clinical Development Team(s)
- Manages team and individual performance appropriately
- May supervise other clinical staff
- Performs other duties as assigned
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PREFERRED EDUCATION AND EXPERIENCE:
- Displays highly developed project leadership qualities
- Deep understanding of Clinical Operations and Drug Development. Expert on assigned protocols
- Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents
- Proactively seeks out and recommends process improvements
- Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
- Communicates clearly and effectively with internal and external key stakeholders
- Routinely mentors and may supervise junior staff. Takes a leadership role in on boarding new personnel
- May contribute to Clinical Development Plans with some oversight
- Consistently demonstrates overall leadership in Clinical Operations
- M.S. (or equivalent experience) and 6+ years of relevant work experience
- B.S. (or equivalent experience) and 8+ years of relevant work experience
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, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. 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.