Top 188 Clinical study manager Jobs in Waltham, Ma

Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $137,800 - $206,800 a year
- Full-time
- Hybrid work
- 6 years
- Project management
- Bachelor's degree
- Loan repayment program
- Dental insurance
Clinical Study Operations Manager
Beacon Biosignals —Boston, MA
- $90,000 - $110,000 a year
- Remote
- English
- Neurology
- Senior level
- Paid time off
Quick Apply
1d
Clinical Trial Manager
Generate Biomedicines —Somerville, MA
- $127,000 - $178,000 a year
- Remote
- Mid-level
- Bachelor's degree
- Travel
8d
Lead Clinical Study Manager (Lead CSM)
Takeda Pharmaceutical —Boston, MA
- $116,000 - $182,270 a year
- Full-time
- Remote
- 6 years
- Doctoral degree
- Bachelor of Science
- Paid holidays
- Disability insurance
3d
Clinical Trial Manager
Kymera Therapeutics —Watertown, MA
- $115,000 - $200,000 a year
- Bachelor of Science
- HIPAA
- Bachelor's degree
Quick Apply
Region Manager
Care Access —Boston, MA
- $95,000 - $115,000 a year
- Up to 50% travel
- Inventory management
- Pass drug screening
- Health savings account
- Paid holidays
RN Pediatric Clinical Research - PRN
Professional Case Management —Boston, MA
- $65 an hour
- PRN
- CPR Certification
- Nursing
- Clean driving record
- On-the-job training
Quick Apply
8d
Director, Clinical Data Management Operational Delivery
Takeda Pharmaceutical —Boston, MA
- $177,000 - $278,080 a year
- Full-time
- Remote
- 7 years
- Writing skills
- Supervising experience
- Paid holidays
- Disability insurance
Associate Director, Clinical Operations Program Lead
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Remote
- English
- Bachelor's degree
- Conflict management
- Paid holidays
- Disability insurance
Clinical Trial Manager
TransMedics, Inc. —Andover, MA
- $112,400 - $140,200 a year
- Full-time
- Bachelor of Science
- Office
- Analysis skills
- Employee stock purchase plan
- Disability insurance
Quick Apply
8d
Principal Clinical Trial Manager
TransMedics, Inc. —Andover, MA
- $137,100 - $193,700 a year
- Full-time
- Bachelor of Science
- Office
- Master's degree
- Employee stock purchase plan
- Disability insurance
Quick Apply
8d
Clinical Project Manager
Sionna Therapeutics Inc —Waltham, MA
- $130,000 - $150,000 a year
- Full-time
- Hybrid work
- 5 years
- Databases
- Bachelor's degree
Central Study Coordinator I
Care Access —Boston, MA
- $75,000 - $95,000 a year
- Remote
- Spanish
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Paid holidays
10d
Study Manager I
DM CLINICAL RESEARCH GROUP —Brookline, MA
- $80,000 - $105,000 a year
- Customer service
- 5 years
- Writing skills
Clinical Trial Manager
Seaport Therapeutics —Boston, MA
- $133,000 - $150,000 a year
- Bachelor of Science
- Office
- Bachelor's degree
4d
Senior Clinical Trial Manager (CTM)
Praxis Precision Medicines, Inc. —Boston, MA
- $168,000 - $188,000 a year
- Email
- Remote
- 5 years
- Bachelor's degree
- Contracts
Quick Apply
Clinical Research Associate II
AbbVie —Boston, MA
- $84,500 - $162,000 a year
- Full-time
- Remote
- Nursing
- Mid-level
- Organizational skills
- Paid holidays
- Health insurance
Senior Clinical Trial Manager
Treeline Biosciences —Watertown, MA
- $153,000 - $197,600 a year
- 5 years
- Office
- Bachelor's degree
Quick Apply
2d
Clinical Trial Manager/Senior Clinical Trial Manager
Oruka Therapeutics —Waltham, MA
- $146,000 - $187,000 a year
- Hybrid work
- 5 years
- Office
- Master's degree
Clinical Operations Manager
Tessera Therapeutics —Somerville, MA
- $164,000 - $199,000 a year
- Microsoft Word
- Microsoft Excel
- 8 years
- Disability insurance
- Health insurance
9d

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Senior Manager, Clinical Study Quality Lead (Hybrid)

Vertex Pharmaceuticals -
Boston, MA

Apply Now

Job Details

Full-time
$137,800 - $206,800 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Quality control corrective actions
Risk management compliance audits
Investigations regulatory compliance
Defect resolution root cause analysis
Clinical trial risk management
Clinical research audit management
Preventive action implementation
Corrective and preventive actions (CAPA)
Internal investigations
Quality control audit
Clinical audit and monitoring
ICH guidelines
Project management
Regulatory readiness in healthcare
Audit risk assessments
Research regulatory compliance
Clinical quality assurance standards
Root cause analysis
Clinical program risk management
Cross-functional communication

Full Job Description

Job Description

General Summary:

The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. The ideal candidate brings direct, hands-on GCP QA experience supporting clinical trials in a sponsor, CRO, or similarly regulated clinical research environment. This position is on-site or hybrid and is not eligible for a fully remote work arrangement.

Key Duties and Responsibilities:

Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance to clinical study teams and key stakeholders.
Partner cross-functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and maintain inspection readiness.
Conduct risk-based quality reviews of protocols, informed consent documents, and other key study documentation to identify potential compliance and operational risks.
Advise clinical study teams on quality risks and support the development of practical, risk-based mitigation strategies.
Develop and oversee investigator site audit plans for assigned studies, ensuring alignment with study risk, audit strategy, and company expectations.
Lead and/or support domestic and international investigator site audits and inspection readiness activities.
Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed, addressed, and resolved in a timely manner.
Support quality issue investigations, including root cause analysis, CAPA planning, and follow-up of effectiveness measures.
Review and monitor clinical quality data, compliance signals, and study-level trends, escalating significant risks or concerns as appropriate.
Contribute to ongoing process improvement and continuous quality initiatives to strengthen GCP compliance across clinical programs.
Support regulatory agency inspections at Vertex and/or clinical investigator sites, as needed.
May contribute to the review of SOPs, work instructions, and internal guidance documents that support the clinical quality management system.

Required Experience:

Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience providing oversight for clinical trials, or the equivalent combination of education and experience.
Candidates must have direct, hands-on experience providing GCP QA oversight for clinical trials.
Experience supporting clinical study quality in a sponsor, CRO, or similarly regulated clinical research environment.
Experience supporting clinical development programs for drugs and biologics.

Required Knowledge/Skills:

Strong knowledge of ICH GCP E6(R3) and applicable global clinical trial regulations and guidance.
Demonstrated experience in GCP clinical trial quality oversight, including audit support, inspection readiness, quality issue management, root cause analysis, and CAPA.
Ability to identify GCP compliance risks, assess impact, and apply risk-based quality principles in a clinical trial environment.
Strong communication skills, with the ability to work effectively across internal and external stakeholders.
Ability to work independently, manage multiple priorities, and deliver high-quality work in a fast-paced environment.
Strong organizational, project management, and problem-solving skills.

Preferred Skills:

Experience supporting devices, combination products, or cell and gene therapy clinical trials.
Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit is highly desirable.
Professional certification such as RQAP-GCP, CCRP, or similar.

Other Requirements:

Up to 10% travel may be required.

Pay Range:

$137,800 - $206,800

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:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. 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-Hybrid

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]

Apply Now

Refine Your Search

clinical study manager jobs in waltham, ma

Senior Manager, Clinical Study Quality Lead (Hybrid)

Clinical Study Operations Manager

Clinical Trial Manager

Lead Clinical Study Manager (Lead CSM)

Clinical Trial Manager

Region Manager

RN Pediatric Clinical Research - PRN

Director, Clinical Data Management Operational Delivery

Associate Director, Clinical Operations Program Lead

Clinical Trial Manager

Principal Clinical Trial Manager

Clinical Project Manager

Central Study Coordinator I

Study Manager I

Clinical Trial Manager

Senior Clinical Trial Manager (CTM)

Clinical Research Associate II

Senior Clinical Trial Manager

Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Operations Manager

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