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Clinical Trial Risk Based Monitoring Jobs in Massachusetts

Tango Therapeutics

Clinical Trials Manager

Boston, MA · On-site

Monitor CRO/ vendor performance and ensure timely and accurate data integration, transfer, and ... Knowledge of trial risk assessment and management * Familiarity with clinical trial systems (e.g ...

Verastem

Clinical Trial Manager

Boston, MA · On-site

$100K - $125K/yr

... develop risk mitigation plan. * Oversee monitoring activities at clinical CROs by reviewing ... Your actual base salary will be based on several factors, including job-related skills, experience ...

Prometrika LLC

Clinical Trial Manager

Cambridge, MA · On-site

$140K - $168K/yr

... site monitoring oversight, clinical vendor management, clinical trial risk management, TMF ... management, and regulatory submissions (e.g., CSR, NDA support). * Experience working in cross ...

Verastem

Clinical Trial Manager

Boston, MA · On-site

$100K - $125K/yr

... develop risk mitigation plan. * Oversee monitoring activities at clinical CROs by reviewing ... Your actual base salary will be based on several factors, including job-related skills, experience ...

Clinovo

Clinical Trial Manager

Cambridge, MA · On-site

$175K/yr

The Clinical Trial Manager (CTM) plays a key role in the successful execution of clinical research ... monitoring activities, and risk mitigation efforts. * Evaluate vendor deliverables, performance ...

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Clinical Trial Risk Based Monitoring information

What is clinical trial risk based monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

How does a clinical trial risk based monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

What are the key skills and qualifications needed to thrive in clinical trial risk based monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Massachusetts?

For Clinical Trial Risk Based Monitoring jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Massachusetts look for?

The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Massachusetts are:

What cities in Massachusetts are hiring for Clinical Trial Risk Based Monitoring jobs?

Cities in Massachusetts with the most Clinical Trial Risk Based Monitoring job openings:

Clinical Trial Risk Based Monitoring jobs near you
Infographic showing various Clinical Trial Risk Based Monitoring job openings in Massachusetts as of August 2026, with employment types broken down into 86% Full Time, and 14% Part Time. Highlights an 100% In-person job distribution.

Clinical Trials Manager

Tango Therapeutics

Boston, MA • On-site

Full-time

Posted 8 days ago

Job description

Company Overview
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary
We are seeking a Clinical Trial Manager (CTM) to lead operational aspects of a clinical trial and support the Clinical Trial Leader (CTL), as required. This role will serve as a key member of the Clinical Trial Team (CTT) and as the primary contact for external parties and vendors. CTM may lead the cross-functional CTT for smaller and less complex trials or manage critical aspects of larger and more complex clinical trials under CTL leadership. In addition, CTM will be responsible for site management oversight for trials where no Site Management Leader (SML) is assigned.
In a fast-paced, small biotech environment, the CTM will operationally manage the set-up, conduct and reporting of clinical trials (or parts thereof) as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives.
The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.
Your Role:
  • Serve as a core member of the Clinical Trial Team (CTT) and act as deputy for the Clinical Trial Leader (CTL) during absences
  • Organize and coordinate CTT meetings, including preparing agendas, recording minutes, and tracking follow-up actions
  • Facilitate communication and collaboration within the team and with external partners such as Contract Research Organizations (CROs) and vendors
  • Contribute to the development and maintenance of trial-level documents and operational plans, including project management, communication, risk management, and quality plans
  • Establish and manage trial-related systems and processes (e.g., central laboratories, eCOA/ ePRO) in alignment with protocol requirements
  • Monitor CRO/ vendor performance and ensure timely and accurate data integration, transfer, and reconciliation. Escalate issues to the CTL, as needed
  • Identify risks and issues and support the development and implementation of mitigation strategies and action plans
  • Maintain accurate and up-to-date trial information in systems and communication tools
  • Set up and maintain clinical trial insurance in participating countries
  • Coordinate with the global supply chain to ensure timely supply and distribution of devices and investigational medicinal products, comparator or co-medication to clinical sites
  • Prepare and distribute trial-related correspondence and contribute to the development of materials for meetings, newsletters, and websites
  • Lead logistical arrangements and support content development for external meetings such as investigator meetings and advisory boards
  • Ensure ongoing inspection and audit readiness. Participate in internal audits and regulatory inspections, as required
  • Support budget forecasting and accrual processes. Assist with invoice tracking, and processing in line with vendor contracts
  • Act as CTL when assigned, leading cross-functional CTT to operationalize the protocol of a clinical trial
  • Lead the development of site management oversight plan and ensure site management oversight including risk management for trials without assigned Site Management Lead (SML)

What You Bring:
  • 5+ years of trial management experience. Leadership experience (preferred)
  • Bachelor's degree in Life Sciences, Pharmacy or related field
  • Experience working in global clinical development organization
  • Experience in Oncology development (preferred)
  • Direct experience with health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
  • Experience in outsourcing and oversight
  • Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
  • Knowledge of financial planning, tracking, and reporting
  • Knowledge of trial risk assessment and management
  • Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and site management metrics, KPIs, and KRIs
  • Strong vendor management and project management skills
  • Leadership skills with the ability to lead cross-functional teams
  • Strong interpersonal and communication skills
  • Strong analytical thinking and decision-making capabilities
  • Willingness to travel, as required (typically 10-20%)

#LI-HYBRID
#LI-HYBRI
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
#LI-HYBRID
Salary range
$120,000-$180,000 USD

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