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Clinical Trial Management Manager

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Tuesday, July 9, 2024

Job Description

General Summary:

The Clinical Trial Manager is responsible for project managing regional activities on complex global clinical trials across a range of study phases (Phases I through 4, including Real World Evidence trials) and therapeutic areas. This role is accountable for ensuring key study deliverables are met, quality is maintained throughout the lifecycle of the trial, and the study budget is maintained within the assigned region(s).

Key Duties and Responsibilities:

  • In an in-house operational model (without CROs), leads internal and external clinical trial management activities of all assigned regional study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials
  • Supports operational strategy and overall study timeline development by providing input for the assigned region
  • Implements regional study operational strategy
  • Identifies study risks within assigned region and independently implements contingency plans
  • Contributes to global vendor selection and is directly responsible for vendor set up and oversight activities for assigned vendors, including invoicing
  • Supports Global Clinical Trial Manager in ongoing review of trial budget for the assigned region
  • Leads investigator identification and selection within assigned region
  • Organizes and presents at Investigator Meetings and Site Engagement meetings
  • Travels to investigational sites during start up and early conduct to develop relationships with site personnel
  • Authors study operational plans and is a key contributor to the development of study documentation and patient recruitment materials
  • Supports Global Clinical Trial Manager in preparation of study operational dashboards for senior executives and presentations on study status to senior executives
  • Leads cross functional study data review for assigned region
  • Participates in department level or cross-functional initiatives or process improvement initiatives

Knowledge and Skills:

  • Proficient in project management skills and cross-functional study operations
  • Good understanding of GCP, CFR and ICH Guidelines
  • General experience with vendor management selection, set up and oversight
  • Demonstrates understanding of clinical protocol, intended study populations, and drug development process
  • Demonstrates ability to effectively interface with key medical personnel at investigational site(s)
  • Proficient interpersonal and communication skills to explain complex information to internal and external stakeholders
  • Demonstrates ability to effectively anticipate issues and problem solve independently
  • Excellent attention to detail
  • Ability to work successfully under pressure with tight timelines
  • Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
  • Periodic travel to investigational sites and Investigator Meetings.

Education and Experience:

  • Bachelor's degree in life sciences discipline or related discipline or equivalent relevant experience
  • Typically requires 3 years of relevant work experience in the biopharmaceutical industry or the equivalent combination of education and experience

Pay Range:

$103,440 - $155,160

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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.

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