Principal Clinical Trial Manager (REMOTE)
Vertex Pharmaceuticals3.7
Remote Boston, MA
Job details
Estimated: $71,000 - $91,000 a year
Full time
Job description
Job Description
General Summary:
The Clinical Trial Management Principal is responsible for managing single-region trials of high complexity or leading large multi-center global clinical trials across a range of study phases and therapeutic areas. The role is also responsible for contributing to Clinical Trial Management department initiatives, often as leader.
Key Duties and Responsibilities:
  • Coordinates internal and external clinical trial management activities of all assigned study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials or study regions
  • Assists Clinical Operations Program Lead (COPL) or global Clinical Operations Study Lead (gCOSL) in the development of operational strategy and initial timeline
  • Creates detailed study timeline with minimal support; monitors progress of timeline with cross-functional Study Team input
  • Drives study level operational strategy, overseeing development and execution of study operational plan(s)
  • Drives cross-functional vendor identification and set up and ensures appropriate ongoing oversight
  • Manages approved trial budget(s) including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets
  • Takes lead role in investigator identification and selection
  • Contributes significantly to the development of study documentation including clinical trial protocols, study plans and clinical study reports
  • Proactively identifies study risks and implements contingency plans with minimal supervision
  • Participates in cross functional study data review where appropriate
  • Represents Clinical Trial Management department as a technical resource in cross-functional initiatives or process improvement efforts (e.g. SOP and WI updates), often as leader
  • Acts as a resource for clinical trial management staff with less experience
  • May function as representative for Clinical Trial Management on vendor-related Joint Operating Committees
Knowledge and Skills:
  • Strong clinical trial management track record showing clear proficiency in project management skills, cross-functional study operations and vendor management
  • In-depth understanding of GCP, CFR and ICH Guidelines
  • Demonstrates detailed understanding of clinical protocol, intended study populations and drug development
  • Demonstrates ability to effectively interface with key medical personnel at investigational site(s)
  • Excellent interpersonal skills and communications skills to explain difficult information and works to build alignment
  • Ability to effectively problem solve within a cross-functional team
  • Demonstrates ability to effectively manage issue identification and resolution
  • Excellent attention to detail
  • Ability to work successfully under pressure with tight timelines
  • Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
Education and Experience:
  • Bachelor's degree in life sciences discipline or relevant discipline
  • Typically requires 8 years of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
#LI
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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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Company details

Headquarters

50 Northern Ave Boston, MA 02110

Employee

1001 to 5000

Revenue

$5B to $10B (USD)

Industry

Pharmaceuticals

Company Description
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. We have multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and several ongoing clinical and research programs in CF. Beyond CF, we have a robust pipeline of investigational small molecule medicines in other serious diseases where we have deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, we have a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus. Founded in 1989 in Cambridge, Mass., our global headquarters is now located in Boston's Innovation District and our international headquarters is in London, UK. Additionally, we have research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.
Company ratings
  • Overall
    3.7
  • Company & Benefits
    3.5 / 5
  • Culture & Values
    3.5 / 5
  • Career Opportunities
    3.2 / 5
  • Work/Life Balance
    3.5 / 5
  • Senior Management
    3.3 / 5
Company reviews
"Tough place to work but good benefits"
Former EmployeeSenior Associate Engineer
Difficult place to work. Upper management works you into the ground. Expects everything to be done on tight (unrealistic) timeliness with what basically amounts to a skeleton crew. Company culture is also super "woke", and will send you emails to lecture you about politics and tell you how we're supposed to feel about certain things as "Vertexians". It really annoying if all you want to do is do your job.
Pros:
Cons:

"Fun but very challenging "
Former EmployeeFinancial Analyst
Great Place to work! Always feel as if there is room to grow and learn more. Work can be a lot, but it's always rewarding and the team makes the juice worth the squeeze/

"Fun and supportive environment"
Current EmployeeDirector
Personally. I have only interacted south wonderful and supportive people here. There is a need for this quickly- growing company to streamline decision-making and strategy. It's a good work environment for many people but not all.

"Exellent Management"
Former EmployeeBack Office Medical Assistant
Very Exellent Management. Very Super and nice work place. Very nice owner and Colleagues. All benefits occured to all employees. Insurance for all Employees.