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Clinical Trial Document Management With Tmf Jobs

Tmf Support Analyst Jobs
By LMK Clinical Research Consulting At United States
Provide project teams with outstanding trial and data management
To continuously improve performance and productivity (ensure high skill level), and provide operational excellence through best practices and lesson learned.
Continuously improve performance and productivity (ensure high skill level and
2 years of Clinical Research experience or professional equivalent.
2 years of Document QC experience or professional equivalent.
To develop strong values and foster innovations in TMF process.
Clinical Trial Assistant / Trial Documentation (Tmf)
By Apex Systems At United States
1. Provide start-up and ongoing trial regulatory document management
5. Setup and manage regulatory document trackers/reports as assigned.
6. Maintain a professional approach respecting the dignity and confidentiality of associates, manager, and vendors.
11. Maintain CEUs for SOCRA or ACRP certification.
• Oncology experience preferred. Prior experience managing flow of clinical trial regulatory documents preferred
4. Ensure quality product deliverables at all times.
Director Clinical Data Management (100% With Location Us)
By Noema Pharma At United States
Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
Experience implementing data management best practices, industry data management standards and developing an organization’s data management function.
Minimum 2 years of line management experience or equivalent.
Leads data management activities for outsourced studies and manages vendors responsible for performing those activities from start-up through database lock.
Establish Program(s) or Portfolio level strategies and services; accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
Provides data management expertise and capability in support of global development programs; identifies and executes industry best practices.
Clinical Trial Document Management (Ctdm) Specialist
By Alcon At United States
Enter and maintain site information and document tracking in current clinical trial management systems.
Travel Requirements: minimal to no travel if located in Fort Worth; less than 10% if remote
Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
Basic knowledge of clinical trial processes
Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!
Benefit from working in a highly collaborative and diverse environment, as well as within a welcoming and empowered team.
Clinical Document Management Associate (Tmf /Oncology) - 1 Year Contract – Hybrid- Nc Pharma
By Frankel Staffing Partners At Raleigh-Durham-Chapel Hill Area, United States
Support the management of eTMF documentation issues throughout the lifecycle of a study
Proactive management of clinical documentation and trackers
Experience working with documents at study start-up, during study conduct and close-out will be required
Experience in handling TMF documents during a regulatory inspection will be a plus.
Proactive and smart organizational skills
Excellent documentation skills and detail-orientation
Document Management Specialsit Jobs
By PeopleMakeUS At Summit, NJ, United States
Upload documents into SharePoint system for efficient record keeping and back-up as SharePoint administrator for Global Risk Management
Obtaining updates for inclusions in Risk Management Plans relating to risk minimization activities
Minimum of 3 years' professional experience preferably in pharmacovigilance or in health science, relevant life science/ medical fields
Exceptional verbal, written, and presentation skills.
Experience using eDMS for a variety of tasks.
Coordinate with local affiliates and Distribution Heads Leads to address any outstanding activities that are due to complete for various tasks.
Tmf Specialist / Clinical Trial Associate
By EPM Scientific At Chicago, IL, United States

3-5+ years of industry experience

In-depth knowledge of TMF process

Are you looking for a way to streamline your clinical trial document management? Look no further than TMF! TMF is a comprehensive document management system that helps you manage all your clinical trial documents in one place. With TMF, you can easily store, track, and access all your documents, ensuring that your clinical trial runs smoothly and efficiently. Plus, TMF offers powerful features such as automated document routing, secure document sharing, and real-time document tracking. Take control of your clinical trial document management today with TMF!

Overview Clinical Trial Document Management with TMF (Trial Master File) is a specialized role within the clinical research industry. The role involves managing the documents and records associated with clinical trials, ensuring that they are organized, up-to-date, and compliant with regulatory requirements. Detailed Job Description Clinical Trial Document Management with TMF involves managing the documents and records associated with clinical trials, ensuring that they are organized, up-to-date, and compliant with regulatory requirements. This includes creating and maintaining the Trial Master File (TMF), which is a comprehensive collection of documents and records related to the clinical trial. The TMF must be kept up-to-date and organized in order to ensure that the trial is conducted in accordance with applicable regulations and guidelines. The role also involves creating and maintaining other documents and records related to the clinical trial, such as patient records, investigator agreements, and protocol documents. Job Skills Required
• Knowledge of clinical trial regulations and guidelines
• Knowledge of document management systems
• Strong organizational skills
• Attention to detail
• Ability to work independently
• Ability to work in a team environment
• Excellent communication skills
• Ability to prioritize tasks
Job Qualifications
• Bachelor’s degree in a related field
• Previous experience in clinical research or document management
• Knowledge of clinical trial regulations and guidelines
• Knowledge of document management systems
Job Knowledge
• Knowledge of clinical trial regulations and guidelines
• Knowledge of document management systems
• Knowledge of clinical trial processes and procedures
• Knowledge of medical terminology
Job Experience
• Previous experience in clinical research or document management
• Previous experience in clinical trial document management
Job Responsibilities
• Create and maintain the Trial Master File (TMF)
• Create and maintain other documents and records related to the clinical trial
• Ensure that documents and records are organized, up-to-date, and compliant with regulatory requirements
• Monitor and review documents and records for accuracy and completeness
• Communicate with clinical trial staff and other stakeholders regarding document management
• Provide support and guidance to clinical trial staff regarding document management