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Form of workOverview:
TFS HealthScience is excited to be expanding our TMF Systems and Operationsteam and we are looking for an experienced, highly motivated TMF Associatewho shares our vision of providing clinical research excellence. Our TMF Systems and Operations 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.
TFS HealthScience is looking for a TMF Associate in the United States. We look forward to receiving your application.
We look forward to receiving your application soon!
The Trial Master File Associate (TMFa) is aligned to and managed, under the assigned therapeutic business unit. The TMFa will function operationally as a member of the study team with the responsibility to create, organize, maintain, and oversee the Trial Master File (TMF). The TMFa will work according to company policies, SOPs, work Instructions, regulatory requirements, and Project Manager/Clinical Research Manager delegation.
Responsibilities:
Qualifications:
What can we offer you?
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 is excited to be expanding our TMF Systems and Operationsteam and we are looking for an experienced, highly motivated TMF Associatewho shares our vision of providing clinical research excellence. Our TMF Systems and Operations 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 TMF Associate in the United States. We look forward to receiving your application.
We look forward to receiving your application soon!
The Trial Master File Associate (TMFa) is aligned to and managed, under the assigned therapeutic business unit. The TMFa will function operationally as a member of the study team with the responsibility to create, organize, maintain, and oversee the Trial Master File (TMF). The TMFa will work according to company policies, SOPs, work Instructions, regulatory requirements, and Project Manager/Clinical Research Manager delegation.
Responsibilities:
- Create the study TMF Index as directed by the PM
- Create the first draft of the TMF Plan, implement changes after review, generate final version and distribute final version to the study team
- For electronic TMF, the TMFa is requested to initiate with IT the eTMF at trial, country and
- site level
- Notify study team that TMF is created and ready for document submission
- Actively follow up that the study team is submitting documentation, following the process described in The TMF Plan and that the TMF is submission and inspection ready at all times
- Provides support and training to study team in regard to the TMF workflow and management
- Act as contact person for study team to support on all TMF issues/inquiries
- Identify areas with missing documentation and inconsistencies and follow up with the study
- team for resolution
- Responsible to create and maintain TMF tracker
Qualifications:
- Bachelor’s Degree 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
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.
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 not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.
