Clinical Sample Manager Job at Cabaletta Bio Inc

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

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

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

health and retirement
PTO
stock option plans

Associate Operations Manager, Translational Medicine

The Translational Medicine Group (TMG) supports the clinical development of Caba...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

BS in a biological sciences or biomedical engineering-related field with 3+ years of experience in clinical drug development or an equivalent combination of education and experience
Experience in reviewing clinical protocol-associated documents including informed consent forms (ICFs) is highly preferred
Experience with clinical sample handling and inventory management is highly preferred
Knowledge of requirements for biospecimen acquisition to support downstream analyses (i.e., flow cytometry, immunoassays, PCR, NGS)
Highly organized, with the capacity to prioritize and provide consistent, timely responses working both collaboratively and independently
Strong communication skills required to interact effectively with internal and external stakeholders, senior management, and external CROs
Management of contract research organizations is preferred
Previous exposure to translational science operations in the cell therapy field, including biospecimen sample processing and handling, is advantageous
Strong team orientation and passion for continuous self-development
Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Job Responsibility

Work closely with the Operations Manager, Translational Medicine on the management and handling of clinical samples, both internally and externally, including supporting the shipping and receiving of clinical samples
Sample quality oversight: Including surveying data sources for TMG sample collection, processing and transit issues. Record sample deviations, manage and track implementation of CAPAs where applicable, in collaboration with Central Lab vendor(s) and the Quality team
Vendor Oversight: review invoices, evaluate vendor performance, build relationships with vendors and courier services
Reconcile informed consent for the use of clinical biospecimens to support translational scientists and external partners
Support on-site sample receiving and verification upon sample arrival
Coordinate timely shipments of clinical samples from central labs to testing labs/CROs and to our in-house lab team
Manage concurrent timelines for multiple internal projects
Review relevant sections of clinical study related documents
Support inventory buildout and testing workflows in TMG’s Laboratory Information Management System(s) (LIMS)
Assist in timely review of CRO research contracts and invoices through communication with legal and finance groups respectively

What we offer

health and retirement, PTO, and stock option plans

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meeting
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO

Job Responsibility

Accountable for delivering the clinical operation activities of the study until study archiving
Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings

Fulltime

Clinical Research Coordinator - Immune Effector Cell Therapy Program

The CRC (Clinical Research Coordinator) will work within the Immune Effector Cel...

Location

United States , Brookline

Salary:

48100.00 - 54400.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Excellent organization and communications skills required
Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts
Must be detail oriented and have the ability to follow-through
Ability to effectively manage time and prioritize workload
Must practice discretion and adhere to hospital confidentiality guidelines at all times
Must have computer skills including the use of Microsoft Office
Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required
0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred

Job Responsibility

Support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager
Responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials
Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required
Support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements
May be responsible for pertinent IRB protocol submissions
Screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries
May prepare and or complete regulatory related reports and IRB submissions
Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable

Fulltime

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)

Job Responsibility

Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses
Oversee site contracting and study budget management
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...

Location

United States , Pleasanton

Salary:

173100.00 - 234100.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results

Job Responsibility

Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing and make your life easier
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

Diagnostic Delivery Lead

The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine (OTM) i...

Location

United States; United Kingdom , Collegeville, Pennsylvania; Stevenage; Waltham, Massachusetts

Salary:

151500.00 - 252500.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in biological sciences or related discipline
7+ years of industry experience
Experience in clinical trial specimen management
Experience overseeing third‑party vendors and laboratories, including contracting activities
Professional experience within the Oncology therapeutic area
Experience with diagnostic assay development and validation

Job Responsibility

Drives the implementation of clinical diagnostic plans for therapeutic programs in early and late stage clinical development across Oncology, ensuring audit readiness
Accountable for the development of the clinical study’s diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
Accountable for planning and implementing the diagnostic biosample collection within a clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc.
Accountable for forecasting and planning of biosample analysis and sample management costs within projects or clinical studies
Contributes to study protocols and ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the diagnostic plan
Work with Clinical Operations to draft Site Communications and Training Materials
train CRO and internal teams on sample collection/processing activities as required
Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/data results and is a key contact for the assay lab
Ensures alignment of outputs with the requirements of Data Management and Biostatistics, and provide expert input into data transfer agreements
Serves as first point of contact for diagnostic biosample operational questions and issues within a project and coordinates with internal and external partners (e.g., Laboratory Study Management, Clinical Operations, Diagnostic Leads, and CROs)

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays

Fulltime

Regional Study Coordinator

Labcorp is seeking a Regional Study Coordinator to join our team in Singapore.

Location

Singapore , Singapore

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor Degree in Life Sciences or Pharmaceuticals
3 months or more experience using computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
Professional or internship experience in clinical research or pharmaceutical industry
Proficiency in Chinese language as liaising with China counterparts is expected
Strong interpersonal skills
Influence and negotiation skills
Demonstrated ability to plan and prioritize
Demonstrated communication and organizational skills
Demonstrated attention to detail
Demonstrated participation in process improvement initiatives

Job Responsibility

Be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region
Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the clinical protocol
Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the Asia platforms and through all study stages, from set-up to closure
Review the study Statement of Work, a document that specifies the scope of services CLS will perform for a clinical protocol and contains information approved by the sponsor and necessary to define the protocol specific database, to ensure regional feasibility and make appropriate recommendations to the Study Design Lead
Ensure a detailed knowledge of the Statement of Work specifications and very good understanding of how they impact every lab services aspect of the clinical trial
Manage day-to-day regional study related activities, including responding and resolving challenges in logistics, lab tests resulting, monitoring and study supplies, keeping the Global Study Manager informed of any study development
Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop
Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed
Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan
Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups

Fulltime

Clinical Sample Manager

Cabaletta Bio Inc

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
May 16, 2026

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

Similar Jobs for Clinical Sample Manager

Manager, Clinical Operations, International