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Risk Based Study Monitoring Principal

Semma Therapeutics

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Boston, MA, USA

Posted on Wednesday, September 4, 2024

Job Description

General Summary:

The Risk-based Study Management Principal role is responsible for timely and high quality Risk-based Study Management (RBSM) strategy supporting the Vertex portfolio. This management-level RBSM Lead role is responsible for supporting the study-specific risk assessment process prior to leading the study teams through the periodic risk review process which includes ongoing assessment of Key Risk Indicators (KRIs) to identify issues and emerging risks in clinical trial variables (trends/outliers/poor performing sites) through the review of aggregate data. The RBSM Lead demonstrates an exceptional degree of technical and clinical trial expertise while working directly with the cross-functional study team to support the quality oversight of sites, countries, and studies both within the RBSM platforms via the study-specific analytics as well as the parallel process activities.

Key Duties and Responsibilities:

Facilitates the initial risk assessment activities including documenting the study-specific RBSM strategy

Facilitates review of periodic risk review output with the Study Team and provides recommendations and guidance on actions

Advises the study team on any updates to the monitoring strategy during the study conduct based on the output from the monthly review activities

Oversees the risk review processes for assigned studies

Contributes to the development of standards including tools/templates for RBSM activities (can function as a workstream owner)

Ensures the training of RBSM Central Risk Managers (at all levels) and Study Team members on processes, platforms, tools, and templates

Provides technical expertise to set-up and test study-level Risk Assessment Module and Central Monitoring Modules design in the designated RBSM platform

Provides input on initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines, and deliverables

Contributes to periodic portfolio level risk review with functional area representatives to identify enterprise-level trends, corrective actions, etc.

Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.

Functional/line management of RBSM Central Risk Managers (at all levels)

Performs other duties as assigned

Knowledge and Skills:

Technical expertise and business experience in supporting clinical trial database development, data management, site monitoring, etc.

Thorough understanding of the processes associated with clinical study management and data management

Project management skills and technical capabilities

Works independently, receives instruction primarily on unusual situations

Ability to organize tasks, time, and priorities; ability to multi-task

Effective and appropriate verbal and written communication with internal and external stakeholders, locally and globally

Must have experience with data visualization and data analytics tools

Education and Experience:

Bachelor's degree in relevant discipline (or equivalent degree)

Minimum of 5+ years of relevant work experience in the Biotech or Pharmaceutical industry, or equivalent comparable background

Minimum of 1-2 years’ experience working in centralized monitoring and/or risk-based study management

Pay Range:

$132,800 - $199,200

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

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