Trial Master File Lead
hace 3 semanas
Overview:
TFS HealthScience is excited to be expanding our **TMF Operations and Systems Business **team and we are looking for an experienced, highly motivated **Trial Master File Lead (TMF Lead) **who shares our vision of providing clinical research excellence. Our **TMF Operations and Systems Business **team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.
**Together we make a difference.**
TFS HealthScience is looking for a **Trial Master File Lead (TMF Lead)**:
- office based in Barcelona, Spain.**
**What can we offer you?**
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.
**Spain benefits include**:
- Private Health Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Lunch Allowance
- Homebased Allowance for home-based employees
- Pre-tax scheme for employees who use the nursery ticket system
- Flexible working schedule - which encourages a balanced work and home life
**Responsibilities**:
The **Trial Master File Lead (TMF Lead)** is part of the TMF Operations and Systems Business Line being part of Clinical Operations and TMF Delivery 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, PM delegation and coordinating main task under TMF Business Line and may act as Line Manager for TMF Associates (TMF A).
We are looking for someone who is experienced in clinical trials and study document management. You will be responsible for the coordination, preparation, quality control and delivery of Investigator Site Files. You may be assigned to act as line manager for a team working with ISFs. In addition - you may be assigned to a specific study to manage its documentation.
- Create the Study TMF EDL in cooperation with PM (Project Manager) and study team
- Create first draft of TMF Plan, implement changes after review, generate final version and distribute final version to the study team
- Create TMF at Trial, Country and Site Level (paper TMF)
- Control if the Electronic Trial Master File (eTMF) at Trial, Country and Site Level was properly created by Clinical Business Administrator (CBA) team when TFS system is used
- Inform to study team that TMF is created and ready for document upload for eTMF or submission to paper TMF (pTMF)
- Actively follow up study team is submitting documentation following the process described in The TMF Plan and that TMF the TMF is always audit and inspection ready.
- Set up the Investigator’s File as directed by Clinical Research Manager (CRM) and forward the CRM a tracker of all document sections within the ISF. This activity may be delegated to TMF A and/or Project Management Associate (PMA) depending upon study needs
- Actively collaborates in the training to study Team regarding the TMF workflow and management
Qualifications:
- At least Bachelor’s Degree preferred in Document Administration or Health Science
- 5 and above years of proven relevant experience in Clinical Trials with TMF management including oversight and quality control
- Deep Knowledge of GCP/ICH guidelines
- Strong understanding of the impact of the TMF on the Study management
- Strong written and communication skills and demonstrate ability to communicate and coordinate within the group of TMF stakeholders
- At least 1 year of proven people management
- Strong organizational skills
- Good software and computer skills
- Able to work in a fast-paced environment with changing priorities
- Able to effectively work in a team environment".
- Ability to work independently, to prioritize and demonstrate flexibility
- Effective time management
- Strong organizational skills
- Problem solving skills
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _privacy notice_ for further details._
- TFS HealthScience does
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