CrawlJobs Logo

Clinical Trial Manager

beamtx.com Logo

Beam Therapeutics

Location Icon

Location:
United States , Cambridge

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

125000.00 - 155000.00 USD / Year

Job Description:

Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this role, you will serve as the operational lead - driving timelines, fostering collaboration, and ensuring the successful execution of clinical trials. The CTM will oversee day-to-day activities throughout the clinical trial lifecycle.

Job Responsibility:

  • Manage all project team activities related study start up, conduct and close out activities
  • Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget
  • Manage Change Orders with Sites (and Vendors when necessary)
  • Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF
  • Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities
  • Contribute to (or oversee the management of) the creation of the trial plans and site facing documents
  • Develop (or overseeing the development of) all training/day to day materials
  • Support data management activities
  • Monitor (and escalate appropriately) vendor metrics and vendor performance
  • Organize, oversee and/or participate in all study related meetings
  • Develop and maintain (or oversee) the development of the Trial Master File
  • Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc.

Requirements:

  • Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials
  • Phase I experience is strongly preferred
  • a background in rare disease and/or metabolic disorders is highly desirable
  • experience with cell & gene therapy is a plus
  • Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes
  • Exceptional organizational skills and ability to deal with competing priorities
  • strong reasoning and problem solving ability
  • Ability and willingness to travel up to 20% (domestic and international)

Nice to have:

  • Phase I experience
  • a background in rare disease and/or metabolic disorders
  • experience with cell & gene therapy

Additional Information:

Job Posted:
December 24, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Clinical Trial Manager

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...
Location
Location
Germany; Switzerland
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree or advanced degree in life sciences or related field
  • Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
  • Cell therapy experience preferred and/or focus complex therapies
  • Fluency in English
  • working proficiency in additional European languages a plus
  • Experience with early phase, complex trials
  • Experience managing Contract Research Organizations and other external vendors
  • Good understanding of European regulatory requirements (EMA, MHRA, etc)
  • Working knowledge of GCP/ ICH regulatory guidelines
  • Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management
Job Responsibility
Job Responsibility
  • Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
  • Perform hands-on activities not outsourced to vendors, as needed
  • Author study documents and plans such as ICF and study specific plans
  • Provide input and review of site training materials
  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
  • Proactively identify risks and lead team members to mitigate risks in a timely fashion
  • Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
  • Select and manage vendors
  • Perform and document study-level Sponsor Oversight of outsourced clinical activities
  • Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right

Clinical Trial Operations Associate

Beacon Biosignals is on a mission to revolutionize precision medicine for the br...
Location
Location
United States , Boston
Salary
Salary:
Not provided
beacon.bio Logo
Beacon Biosignals
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in clinical project management or clinical operations roles
  • Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
  • Excellent written and verbal communication skills in English
  • A proactive mindset with the ability to identify priorities and anticipate challenges
  • Meticulous attention to detail, ensuring accuracy in data collection and reporting
  • Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
  • A desire to learn more about analytics, statistics, machine learning, and clinical trials
Job Responsibility
Job Responsibility
  • Collaborate with project teams to support study startup activities
  • Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
  • Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
  • Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
  • Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
  • Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
  • Provide actionable feedback from research sites to inform improvements in devices and workflows
What we offer
What we offer
  • equity
  • PTO
Read More
Arrow Right

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
United States , CARY, BLUE BELL, RAHWAY, NJ
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS/BSc or RN
  • At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
  • Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
  • Strong clinical project management skills and experience in driving milestones
  • Excellent communication and interpersonal skills to effectively work with cross-functional teams
  • Proficient in trial management systems and MS Project (or equivalent PM software)
  • Knowledge of ICH/GCP and regulatory guidelines/directives
Job Responsibility
Job Responsibility
  • Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
  • Develops the strategic scenarios of designs for early phase clinical development plan
  • Ensures standard processes, tools, and procedures are used consistently
  • Routine engagement with Clinical Investigators
  • Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
  • Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
  • Ongoing safety data review and completion of study data collection, data lock, and analysis
  • Resolution of cross-functional study-specific issues
  • Communication of study status to key stakeholder and updating relevant systems
  • Ensures study personnel are appropriately trained and understand study timelines and deliverables
What we offer
What we offer
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Read More
Arrow Right

Ctsu Trial Manager

Our subsidiary Randstad professional solutions is currently offering an attracti...
Location
Location
Germany , Biberach an der Riß
Salary
Salary:
60000.00 - 70000.00 EUR / Year
https://www.randstad.com Logo
Randstad
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master's degree in natural sciences or similar disciplines or completed vocational training with experience in clinical trials
  • Several years experiences in clinical trial supplies or related business
  • Experience in working in an international environment, as well as team leading and project management experiences
  • Ideally good knowledge and understanding of the regulatory and GMP/GCP requirements for IMPs
  • Ability to interpret complex project requirements
  • Good software skills (MS-Office)
  • German language skills, written and spoken
  • Fluency in written and spoken English
  • Strong problem solving capabilities with the willingness to make decisions and the ability to drive results
  • Very good communication, negotiation and presentation skills
What we offer
What we offer
  • Fair compensation
  • Personal support
  • Fulltime
Read More
Arrow Right

Senior Clinical Research Manager - Network Operations

The Senior Clinical Research Manager (CRM) provides strategic and operational ov...
Location
Location
United States , Brookline; Brighton; Milford; Weymouth; Methuen; Foxborough; Londonderry
Salary
Salary:
105400.00 - 130500.00 USD / Year
dana-farber.org Logo
Dana-Farber Cancer Institute
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
  • Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
  • Experience in protocol development, data compilation and analysis.
  • Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
  • Expert knowledge of Federal and State regulations as they relate to research.
  • Strong interpersonal, organizational and communication skills are required.
  • Must have computer skills including the use of Microsoft Office and working knowledge of Livelink
  • EPIC and OnCore applications.
  • Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
  • Is fully proficient in their knowledge of clinical research local policy and federal regulation.
Job Responsibility
Job Responsibility
  • CLINICAL TRIAL OPERATIONS: Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
  • Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
  • Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
  • Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
  • Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
  • Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
  • Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
  • Assists the principal investigator in preparing manuscripts for publication.
  • Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
  • Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
  • Fulltime
Read More
Arrow Right

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or master’s degree with 25+ years of data management experience
  • 10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
  • Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
  • Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
  • Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
  • Understanding of clinical data standards (CDISC, SDTM, ADaM)
  • Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
  • Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
  • Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams
Job Responsibility
Job Responsibility
  • Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
  • Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
  • Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
  • Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
  • Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
  • Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
  • Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
  • Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
  • Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
  • Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data
Read More
Arrow Right

Locum Clinical Trials Pharmacist / Pharmacy Technician

Join our NHS client’s team as a Clinical Trials Pharmacist or Technician and tak...
Location
Location
United Kingdom , Dorset
Salary
Salary:
24.00 - 31.00 GBP / Hour
https://hg-ahp.com Logo
Hunter Gatherer AHP
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • clinical trials experience – this is essential
  • a current and valid GPhC registration (Pharmacist or Pharmacy Technician)
  • prior experience supporting or managing research trials in a hospital setting
  • strong organisational and communication skills
  • ability to work independently and as part of a multidisciplinary team
Job Responsibility
Job Responsibility
  • oversee 15 active clinical trials across renal, oncology, cardiology, and general medicine
  • support setup and coordination of new clinical trials
  • supervise and support a junior team member
  • ensure full compliance with GCP and trial protocols
  • work closely with both the research and pharmacy departments
What we offer
What we offer
  • Fast & simple AHP locum registration
  • A network of like-minded AHP professionals
  • Reliable, high-paying locum jobs with bi-weekly payroll
  • Specialist AHP recruitment consultants
  • Exclusive NHS & private sector job opportunities
  • CV marketing & business development support
  • Industry insights, networking events & discounted CPD
  • Parttime
Read More
Arrow Right

Clinical Trials Pharmacist

We are currently recruiting for a Band 7 Clinical Trials Pharmacist to join a hi...
Location
Location
United Kingdom , London
Salary
Salary:
28.00 - 33.00 GBP / Hour
https://hg-ahp.com Logo
Hunter Gatherer AHP
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Registered with the General Pharmaceutical Council (GPhC)
  • Minimum of 1 year’s experience in clinical trials or hospital pharmacy
  • Previous use of Chemocare and Cerner Millennium highly desirable
  • Strong attention to detail and ability to work independently
  • Excellent communication and time-management skills
Job Responsibility
Job Responsibility
  • Provide specialist pharmacy support to clinical trials within the hospital
  • Collaborate with research teams, clinicians, and pharmacy colleagues to ensure the safe and effective management of Investigational Medicinal Products (IMPs)
  • Ensure compliance with Good Clinical Practice (GCP) and NHS research governance frameworks
  • Contribute to the development and delivery of training and audit processes for clinical trials pharmacy services
What we offer
What we offer
  • Flexible schedule
  • Competitive hourly rate
  • Reliable weekly payment
  • Potential for long-term opportunities
  • Parttime
Read More
Arrow Right