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Clinical Trial Risk Based Monitoring Jobs in Pennsylvania

Novocure

Clinical Trial Lead

Wayne, PA · On-site

$147K - $190K/yr

Oversee study timelines, milestones, deliverables, and risk mitigation plans. * Manage study ... Monitor CRO and vendor performance to ensure quality and compliance. * Support protocol development ...

Icon plc

Sr. Clinical Trial Manager

Blue Bell, PA · On-site

Senior Local Operations Manager - Oncology Solid Tumor - Home Based (US) ICON is a global health ... Ensures high standards for study monitoring by conducting quality local trial team meetings and ...

ICON

Senior Clinical Trial Manager

Blue Bell, PA · On-site

Develop monitoring plans and tools, ensuring effective study oversight. * Optimizing Performance ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

ICON

Senior Clinical Trial Manager

Blue Bell, PA · On-site

Develop monitoring plans and tools, ensuring effective study oversight. * Optimizing Performance ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

Icon plc

Senior Clinical Trial Manager

Blue Bell, PA · On-site +1

Develop monitoring plans and tools, ensuring effective study oversight. * Optimizing Performance ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

Icon plc

Senior Clinical Trial Manager

Blue Bell, PA · Remote

Develop monitoring plans and tools, ensuring effective study oversight. * Optimizing Performance ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

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Clinical Trial Risk Based Monitoring information

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.

How to become a clinical trial risk based monitoring?

To become a clinical trial risk-based monitor, candidates typically need a bachelor's degree in life sciences, healthcare, or related fields, along with experience in clinical research or monitoring. Certification such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) can enhance job prospects. Strong knowledge of Good Clinical Practice (GCP) guidelines and proficiency with electronic data capture (EDC) systems are also important.

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 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.

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 are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Pennsylvania? For Clinical Trial Risk Based Monitoring jobs in Pennsylvania, the most frequently searched job titles are:
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Clinical Trial Risk Based Monitoring jobs near you

Clinical Trial Lead

Novocure

Wayne, PA • On-site

$147K - $190K/yr

Full-time

Posted 23 days ago

Job description

Clinical Trial Lead
Hybrid / Full Time / Chesterbrook, PA
At Novocure, we're working to extend the lives of patients battling some of the most aggressive cancers. Every role here contributes to that mission-and as Clinical Trial Lead, you'll lead the strategic planning, execution, and successful delivery of global outsourced clinical trials that advance innovative therapies for patients.
ABOUT THE ROLE
We are seeking an experienced Clinical Trial Lead to oversee global clinical studies outsourced to Contract Research Organizations (CROs). This role serves as the primary sponsor representative responsible for leading cross-functional study teams, managing CRO performance, overseeing timelines and budgets, mitigating risks, and ensuring studies are executed in compliance with regulatory requirements and quality standards. You'll work independently while partnering with colleagues across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Finance, and external vendors.
WHAT YOU'LL DO
  • Lead cross-functional Clinical Study Teams from study startup through closeout.
  • Serve as the primary liaison between Novocure and CRO partners.
  • Oversee study timelines, milestones, deliverables, and risk mitigation plans.
  • Manage study budgets, change orders, invoices, and financial performance.
  • Monitor CRO and vendor performance to ensure quality and compliance.
  • Support protocol development, feasibility assessments, and study planning.
  • Track KPIs and proactively resolve operational challenges.
  • Support database lock, clinical study reports, audits, inspections, and regulatory submissions.
  • Partner with global colleagues across North America, Europe, and Israel.

ABOUT YOU
You are an experienced clinical operations professional who thrives in complex global studies. You can independently lead outsourced trials, influence cross-functional teams without direct authority, anticipate risks before they become problems, and balance quality, timelines, and budgets while keeping patients at the center of every decision.
Minimum Qualifications
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • 5-7+ years of clinical research experience, including 2-3+ years leading global clinical studies.
  • Experience leading studies from startup through closeout.
  • Experience managing CROs, vendors, study budgets, and project timelines.
  • Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
  • Excellent leadership, communication, and project management skills.

Preferred Qualifications
  • Oncology clinical trial experience strongly preferred.
  • Experience leading other highly complex global studies.
  • Experience with CTMS, eTMF, and EDC systems.
  • Advanced degree (MS, PharmD, or PhD).

HOW YOU'LL WORK
  • Hybrid role supporting our Chesterbrook, PA office.
  • Collaborate regularly with global colleagues across Europe and Israel.
  • Flexibility to support occasional early-morning meetings across time zones.
  • Approximately 10-20% travel as business needs require.

WHAT WE OFFER
The pay range which Novocure expects to pay for this role at the time of this posting is $147,000 - $190,000/yr. This position is also eligible for an annual incentive bonus and restricted stock unit grant in addition to a full range of benefits. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated.
ABOUT NOVOCURE
Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you'll connect, grow, and make a real difference. We're a company with the drive of a startup and the strength that comes with 25 years of success.
Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.
Our patient-forward values
- innovation
- focus
- drive
- courage
- trust
- empathy
#LI-RJ1
Novocure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veteran and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Novocure is committed to providing an interview process that is inclusive of our applicant's needs. If you are an individual with a disability and would like to request an accommodation, please email NovocureRecruitingEEO@novocure.com
If you're excited about this role, please apply.

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