Job Posting for Certified Tumor Registrar (CTR) - Healthcare at John Snow Labs
Company Description
John Snow Labs is an award-winning AI and NLP company, accelerating progress in data science by providing state-of-the-art software, data, and models. Founded in 2015, it helps healthcare and life science companies build, deploy, and operate AI products and services. John Snow Labs is the winner of the 2018 AI Solution Provider of the Year Award, the 2019 AI Platform of the Year Award, the 2019 International Data Science Foundation Technology award, and the 2020 AI Excellence Award.
John Snow Labs is the developer of Spark NLP - the world’s most widely used NLP library in the enterprise - and is the world’s leading provider of state-of-the-art clinical NLP software, powering some of the world’s largest healthcare & pharma companies. John Snow Labs is a global team of specialists, of which 33% hold a Ph.D. or M.D. and 75% hold at least a Master’s degree in disciplines covering data science, medicine, software engineering, pharmacy, DevOps and SecOps.
Job Description
We are looking for rockstar TMF Consultant in the healthcare space, preferably experience with Clinical trials and pharmacovigilance.
General Overview
Provide guidance to clients on TMF standard operating procedures, processes, and best practices, and technology.
Provide guidance and support for TMF training.
Provide operational excellence through best practices and lessons learned.
Position Overview
The TMF Consultant is the single point of contact for the client for all TMF projects and will:
Define clinical trial documentation migration strategy, ensure compliance with regulatory and customer requirements and best practices.
Ensure clinical trial documentation is in compliance with Trial Master File specifications, submission/test readiness criteria, and applicable SOPs and other requirements.
Provide guidance to support how to achieve consistency through the use and application of standards.
Act as TMF subject matter expert for applicable technologies and procedures used by the customer.
Key Responsibilities
Develop or advise the client on TMF specifications, including standard operating procedures, TMF plans, guides, or process documents.
Create or advise the client on inspection and/or audit readiness plans for TMF content.
Create or advise the client on document quality policies (which may include tools and resources).
Create or advise the client on documentation flow activities with appropriate guidance documents.
Actively identify or advise the client on continuous improvement opportunities to improve operational efficiency through process and metric analysis.
Create or advise the client on metrics program that can monitor performance against targets to ensure program performance is achieved and productivity is aligned.
Create or advise clients on document quality requirements.
Develop TMF training specifications that can be used internally or externally by John Snow Labs.
Education and training requirements.
Minimum of Bachelor's degree or equivalent.
Clinical documentation management and industry experience that provides a comprehensive understanding of the processes associated with clinical trial execution and document management.
Excellent verbal and written communication skills combined with excellent listening skills.
Track record in a customer service role with evidence of meeting customer needs and concerns.
Negotiation and conflict resolution skills are essential, and the ability to remain calm and focused in stressful situations is critical.
Lean Six Sigma certification (or equivalent).
5 years of relevant clinical research experience with an understanding of clinical drug development and clinical trial operations.
1-2 years of CRO experience
Contract
Part-time, intermittent contract, depending on a project setup
Initially, around 25-50 hours will be needed to prepare a workshop. Then, during the project, around 10-20 hours a week.
Qualifications
Key Responsibilities
Develop or advise the client on TMF specifications, including standard operating procedures, TMF plans, guides, or process documents.
Create or advise the client on inspection and/or audit readiness plans for TMF content.
Create or advise the client on document quality policies (which may include tools and resources).
Create or advise the client on documentation flow activities with appropriate guidance documents.
Actively identify or advise the client on continuous improvement opportunities to improve operational efficiency through process and metric analysis.
Create or advise the client on metrics program that can monitor performance against targets to ensure program performance is achieved and productivity is aligned.
Create or advise clients on document quality requirements.
Develop TMF training specifications that can be used internally or externally by John Snow Labs.
Education and training requirements.
Minimum of Bachelor's degree or equivalent.
Clinical documentation management and industry experience that provides a comprehensive understanding of the processes associated with clinical trial execution and document management.
Excellent verbal and written communication skills combined with excellent listening skills.
Track record in a customer service role with evidence of meeting customer needs and concerns.
Negotiation and conflict resolution skills are essential, and the ability to remain calm and focused in stressful situations is critical.
Lean Six Sigma certification (or equivalent).
5 years of relevant clinical research experience with an understanding of clinical drug development and clinical trial operations.
1-2 years of CRO experience
Contract
Part-time, intermittent contract, depending on a project setup
Initially, around 25-50 hours will be needed to prepare a workshop. Then, during the project, around 10-20 hours a week.
Additional Information
We are a fully virtual company, collaborating across 22 countries.
Open to candidates worldwide - work remotely from anywhere.
This is a contract opportunity, not a full-time employment role.
This role requires the availability of at least 10 to 20 hours per week.
Salary.com Estimation for Certified Tumor Registrar (CTR) - Healthcare in Lewes, DE
$53,045 to $69,295
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