TMF Manager Job at Cabaletta Bio Inc (Philadelphia)

Tmf study owner

The TMF Study Owner provides pivotal support and subject matter expertise (SME) ...

Location

United States , Remote

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree level education preferred, but equivalent work experience in a relevant field considered
5 years’ relevant industry experience in Clinical or TMF Operations oversight
Excellent knowledge of Good Documentation Practices (GDP) and document recognition
Good knowledge of referencing/applying applicable resources
Working knowledge of: Clinical trial lifecycle, TMF Reference Model (or equivalent), eTMF systems, TMF Health & Metrics, including Quality Review process, Internal communication/escalation pathways
Familiar with: TMF lifecycle, Other clinical/document management systems, TMF stakeholders, End-to-end tasks, including TMF set-up process and Management Plans, TMF training, Inspection Readiness, External communication/escalation pathway
Proficient in verbal and written communication

Job Responsibility

Document Management & Quality: Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices
TMF Management: Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements
Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented
Monitor milestones and events to ensure TMF Completeness via eTMF functionality
Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team
Support study team through closeout and archive preparations
Ensure ongoing adherence to TMF SOPs and specifications
Create study-specific TMF Index (or equivalent)
TMF Health & Metrics: Perform and/or support Quality Review and perform spot-checks for quality oversight
Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining

What we offer

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day
In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more

Fulltime

TMF Lead

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, nursing, or business administration
advanced degree preferred
Proven experience in TMF management or clinical trial document management, preferably within the healthcare or clinical research industry
Strong understanding of regulatory requirements and industry standards related to TMF and clinical documentation
Excellent organizational skills and attention to detail, ensuring compliance and accuracy in TMF management
Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams
A commitment to promoting equity and inclusion in all aspects of TMF management

Job Responsibility

Leading the setup, maintenance, and oversight of the TMF in compliance with regulatory standards and internal policies
Collaborating with cross-functional teams to ensure timely and accurate documentation within the TMF
Conducting regular TMF quality checks and audits to identify and resolve discrepancies or issues
Providing training and support to team members on TMF processes and best practices
Establishing and implementing strategies for continuous improvement in TMF management and documentation practices

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

Global Site Start Up II

In this role you will be is accountable for the global execution of site activat...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor degree
Minimum 4 - 6 years regulatory submission experience, regulatory document management in Pharmaceutical /CRO industry
understanding of clinical study start up requirements and working knowledge of relevant documentation
Project Management and Clinical Trial Management experience is a must
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across key stakeholders

Job Responsibility

Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans
Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc
Ensure timely country submission deliverables (ensure task completion
all roles clarity, identification of critical path items, effective communication pathway)

Fulltime

GCP QA Consultant

Proclinical is seeking a GCP QA Consultant to support quality assurance activiti...

Location

Germany , Berlin

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong knowledge of ICH-GCP guidelines and regulatory requirements
Experience in quality assurance for clinical trials, particularly in phase 2-3 studies
Proficiency in risk management and quality oversight processes
Ability to manage and maintain TMF documentation and ensure inspection readiness
Skilled in identifying deviations, implementing corrective actions, and driving process improvements
Excellent communication and collaboration skills to work with cross-functional teams and external partners
Familiarity with Clinical Trial Agreements, site feasibility, and activation processes
Leadership and mentoring abilities to guide junior team members

Job Responsibility

Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans
Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking
Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements
Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings
Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements
Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events
Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans
Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes
Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready

Fulltime

TMF Specialist

Piper Companies is looking for a TMF Specialist to join a clinical research orga...

Location

United States , Bethesda

Salary:

20.00 - 25.00 USD / Hour

Piper Companies

Expiration Date

Until further notice

Requirements

Experience working with eTMF systems
Veeva Vault or Trial Interactive preferred
Strong understanding of clinical research processes and document management requirements
In-depth knowledge of ICH-GCP guidelines and regulatory requirements related to TMF management
Excellent organizational skills with strong attention to detail
Effective written and verbal communication skills
Ability to manage multiple priorities in a fast-paced, deadline-driven environment
Strong problem-solving and analytical skills
Experience advising project teams on TMF-related issues
Experience training, mentoring, and coaching staff

Job Responsibility

Managing TMF set-up, quality oversight, reporting, metrics, and quality control activities
Maintaining overall TMF document quality and completeness, including proper filing, coordination, tracking, and reporting
Ensuring clinical trial documentation complies with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and internal SOPs
Accurately maintaining all TMF records in accordance with SOPs and data standards to support inspection readiness
Responding to client requests for TMF retrieval, reproduction, re-filing, and delivery of electronic records
Supporting the development and maintenance of TMF training materials, SOPs, and guidelines, including training staff as needed
Assisting with audit and inspection readiness activities and ensuring the TMF remains inspection ready
Staying current on TMF Reference Model standards, regulatory requirements, and industry best practices
Serving as a liaison between eTMF records management and internal and external clients
Monitoring project activities to ensure deadlines and deliverables are met

What we offer

Cigna Medical/Dental/Vision
401K
Sick Leave as Required by Law

Fulltime

Senior Clinical Study Associate

Be the backbone of clinical research-join a team shaping tomorrow's therapies. P...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong understanding of clinical trial processes and regulatory requirements
Experience with TMF management and document tracking
Proficiency in managing laboratory vendors and coordinating sample logistics
Ability to review and analyze site performance metrics and monitoring reports
Excellent organizational and communication skills
Familiarity with site contracts, budgets, and feasibility assessments
Ability to work collaboratively with cross-functional teams and external vendors

Job Responsibility

Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring
Support the Clinical Study Manager and team members in managing trial activities
Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder)
Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF)
Monitor patient status at investigative sites and ensure accurate tracking
Manage sample collection, laboratory testing schedules, and central laboratory reporting
Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting
Review monitoring trip reports, track data query reports, and assess site visit metrics and performance
Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs
Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues

Clinical Data Analyst

AB Science is hiring a Clinical Data Analyst based in Paris. Responsibilities co...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management
Knowledge of clinical development process
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Job Responsibility

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan
Ensure Clinical Data Management input to other relevant strategic study documents and vendor contracts
Detect important medical events
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database
Detect the forbidden concomitant treatments as per study protocol
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team
Archive documents in the clinical data management TMF

What we offer

Permanent position
Salary & package to define according skills and experience

Fulltime

Clinical Site Associate (In-House CRA)

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Turkey , Ankara

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively
Fluent in English and local language, with good verbal and written communication skills

Job Responsibility

Site Support & Oversight: Manage site-level communications, coordinate site trainings and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items
Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness
perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable
Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF
assist with eCRF UAT testing and clinical sample tracking
Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements
Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations
support SAE and external data submissions and follow up
Site Relationship Management: Support the CRA in establishing and maintaining strong site relationships. CSA needs to understand site-specific processes, and act as a back-up point of contact for the CRA
or as a primary point of contact when needed

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

Fulltime

TMF Manager

Cabaletta Bio Inc

Location:
United States , Philadelphia

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 10, 2026

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Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:April 10, 2026

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Job Posted:
April 10, 2026