Trial Master File Associate

Iriscube Reply; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global Contract Research Organization is seeking a Trial Master File Associate. This role involves managing the Trial Master File, ensuring compliance, and collaborating with study teams to facilitate documentation processes. Applicants should have 1-5 years of experience in the CRO or pharmaceutical industry, with a mandatory 3 years of TMF experience. This position offers a competitive compensation package along with strong career development opportunities in a supportive environment.

Servizi

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Competenze

• 1-5 years of experience in CRO or Pharmaceutical Industry with proven TMF management.
• No less than 3 years of TMF experience and 1+ years of OPH experience.
• Knowledge of GCP / ICH guidelines is essential.

Mansioni

• Organize and maintain the Trial Master File according to policies.
• Notify the study team when TMF is ready for document upload.
• Provide TMF Monthly Reports to PM and Line manager.

Conoscenze

TMF Management

Good written and communication skills

Organizational skills

Time management

Teamwork ability

Formazione

Bachelor’s Degree in Health Science or Document Management

Descrizione del lavoro

3 giorni fa

Join Our Team as a Trial Master File Associate - home based in Poland, Italy or Israel or hybrid in Barcelona, Spain

About this role

As part of our CDS Ophthalmology Trial Master File team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Trial Master File Associateis is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead and PM delegation.

Key Responsibilities :

• Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF

Develop TMF Plan

• Provide training on study specific TMF requirements, guidelines including TMF Plan
• Perform QC2 on documents and documents reconciliation
• Provide TMF Monthly Reports to PM, Line manager and Head of TMF Delivery
• Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics

Ensure TMF processes timely implementation and execution

• Adjusting study specific TMF Index / EDL in the relevant files / system as directed by the PM (Project Manager)
• Ensure valid forms and templates are implemented and maintained in the assigned projects
• Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly
• Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status
• Ensure TMF AoR completion and monitoring TMF transfer / shipment to the Sponsor
• Ensure delivery of fully executed TMF AoR to TMF Functional lead
• Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready
• Act as contact person for study team to support on all TMF issues / inquiries independently
• Identify general areas with missing documentation and inconsistencies and follow up with the study team for resolution
• Actively taking part in Study Team meetings and updates on the TMF status
• Assist and attend activities associated to quality controls, audits and regulatory inspections in relation to the TMF
• Identify TMF quality issues and elevate to the CRM / PM / Director, TMF Functional lead and collaborate in the action plans development
• Resolve in cooperation with Study team all issue identified by Sponsor after TMF transfer

Set up the Investigator Site File (ISF)

• Actively contribute to the organization and development of routines to enhance the work at TFS
• Develops and maintains an effective relationship with the study teams
• Other, as identified by Line Manager

Qualifications :

• At least 1-5 year of experience in CRO or Pharmaceutical Industry with proven TMF Management.
• No less than 3 years of TMF experience (mandatory) with 1+ years of OPH experience (ideal)
• Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred
• Knowledge of GCP / ICH guidelines
• Good written and communication skills
• Good organizational and multi-tasking skills
• Good software and computer skills
• Able to work in a fast-paced environment with changing priorities
• Teamwork ability
• Effective time management

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution‑driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision‑making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.

Master • Metropolitan City of Naples, Campania, .IT