Clinical Monitoring Associate Director

Posted 3 Days Ago
Be an Early Applicant
Hiring Remotely in Boston, MA, USA
In-Office or Remote
157K-236K Annually
Senior level
Biotech • Pharmaceutical
The Role
Leads clinical monitoring operations, managing CRAs and Lead CRAs, overseeing site quality and compliance, reviewing monitoring metrics, allocating resources, developing training and processes, and supporting audits, inspections, CAPA plans, and regulatory readiness across clinical studies.
Summary Generated by Built In

Job Description

General Summary:

The Clinical Monitoring Associate Director is responsible for ensuring on-time monitoring and quality delivery of all required work assignments within the Clinical Monitoring function. Responsible for clinical monitoring training and quality oversight to ensure compliance with Good Clinical Practice and regulations. This position will also work closely with other functions in the Global Clinical Operations (GCO) team to report on clinical site management, important study specific and program updates, as well as process development for clinical monitoring.

Key Duties and Responsibilities:

  • Manages and provides direction to CRAs and Lead CRAs, encouraging engagement, innovation and open communication while supporting Vertex and Global Clinical Operations goals
  • Conducts Quality Oversight Visits as required to assess relationship and effectiveness of CRAs work while on site
  • Reviews visit reports and metrics to evaluate for compliance and trends, escalating issues and involvement in the development of corrective and preventative actions
  • Assists in resource allocation projections/forecasting and site assignments throughout the clinical study(ies) lifecycle, ensuring proper clinical site performance and oversight is achieved; may monitor and evaluate Clinical Research Associate (CRA) and Lead CRA workloads and liaise with the Clinical Monitoring management team to ensure appropriate allocation of resources and optimal utilization and workload
  • Contributes to developing and updating best practices and processes and provides input on discussions around quality by design and operational delivery
  • Develop content and deliver training on Clinical Monitoring processes for new hire on-boarding and ongoing department training, ensuring the department is compliant with Vertex procedures, ICH-GCP and local regulations
  • Leads the on-time and high-quality clinical monitoring by CRAs, ensuring CRAs maintain their sites inspection ready for health authority inspections and audits at all times
  • Represents Clinical Monitoring for audits/inspections as needed, leading the development of CAPA plans and investigations, ensuring inspection findings are remediated and processes are implemented within Clinical Monitoring
  • Knowledge and Skills:

  • Fundamental knowledge of Clinical Research, and expertise in all phases of clinical trials; comprehensive knowledge and understanding of ICH-GCP Excellent management skills with a remote team, developed with a collaborative approach to problem solving, driving performance and success in a global environment
  • Strong interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements
  • Ability to successfully coach and mentor other team members
  • Ability to successfully execute programs in a fast-paced environment managing multiple priorities
  • Ability to travel up to 30% of the time
  • Education and Experience:

  • Bachelor's degree or equivalent relevant experience required
  • Typically requires 8 years of experience, including extensive Clinical Research experience with strong experience in clinical site monitoring, including a Lead CRA role, or experience working as a Project Manager, CRA Manager or equivalent, or the equivalent combination of education and experience

  • At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

    Pay Range:

    $157,200 - $235,800

    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. 

    #LI-Remote

    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 [email protected]

    Skills Required

    • Bachelor's degree or equivalent relevant experience
    • Typically 8 years of experience
    • Extensive clinical research experience
    • Strong clinical site monitoring experience
    • Experience as a Lead Clinical Research Associate, CRA Manager, Project Manager, or equivalent
    • Comprehensive knowledge of clinical trials across all phases
    • Knowledge and understanding of ICH-GCP
    • Clinical monitoring management and team leadership experience
    • Ability to travel up to 30% of the time

    Vertex Pharmaceuticals Compensation & Benefits Highlights

    The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.

    • Parental & Family Support Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
    • Leave & Time Off Breadth Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
    • Retirement Support Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.

    Vertex Pharmaceuticals Insights

    Am I A Good Fit?
    beta
    Get Personalized Job Insights.
    Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

    The Company
    HQ: Boston, MA
    5,000 Employees
    Year Founded: 1989

    What We Do

    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 3,500 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.

    Similar Jobs

    PagerDuty Logo PagerDuty

    Territory Executive - Illinois

    Artificial Intelligence • Cloud • Information Technology • Machine Learning • Software • Big Data Analytics • Automation
    Easy Apply
    Remote or Hybrid
    USA
    1200 Employees
    105K-127K Annually

    PagerDuty Logo PagerDuty

    Enterprise Account Executive

    Artificial Intelligence • Cloud • Information Technology • Machine Learning • Software • Big Data Analytics • Automation
    Easy Apply
    Remote or Hybrid
    USA
    1200 Employees
    131K-171K Annually

    Vestmark, Inc. Logo Vestmark, Inc.

    Senior Trader

    Fintech • Software
    Easy Apply
    Remote or Hybrid
    United States
    400 Employees
    100K-115K Annually

    Liberty Mutual Insurance Logo Liberty Mutual Insurance

    Senior Consultant

    Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
    Remote or Hybrid
    3 Locations
    40000 Employees
    106K-197K Annually

    Similar Companies Hiring

    SOPHiA GENETICS Thumbnail
    Software • Healthtech • Biotech • Big Data • Artificial Intelligence
    Boston, MA
    450 Employees
    Pfizer Thumbnail
    Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
    New York, NY
    121990 Employees
    Cencora Thumbnail
    Healthtech • Logistics • Pharmaceutical
    Conshohocken, PA
    51000 Employees

    Sign up now Access later

    Create Free Account

    Please log in or sign up to report this job.

    Create Free Account