TMF Specialist
60K–80K a year
Behavioral Health Market Context
Apply Nowvia Learn4Good
Job Description
. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials.
Responsibilities:
• Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
• Maintains study-specific TMF Management Plan.
• Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines
• Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
• Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
• Assessing outstanding issues and following through to resolution
• Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team.
• Plan, execute, and lead study-specific meetings.
• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
• Supports other trial-related operational activities as needed and assigned
Requirements
• Bachelor’s Degree Required
• 3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management
• Working knowledge of VEEVA Vault
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point
• Exceptional attention to detail.
• Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills are required
• Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
• Highly responsive and proactive, a team player
• Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment.
• Flexible attitude with respect to work assignments and new learning
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
#J-18808-Ljbffr
Responsibilities:
• Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
• Maintains study-specific TMF Management Plan.
• Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines
• Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
• Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
• Assessing outstanding issues and following through to resolution
• Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team.
• Plan, execute, and lead study-specific meetings.
• Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
• Supports other trial-related operational activities as needed and assigned
Requirements
• Bachelor’s Degree Required
• 3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management
• Working knowledge of VEEVA Vault
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point
• Exceptional attention to detail.
• Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills are required
• Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
• Highly responsive and proactive, a team player
• Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment.
• Flexible attitude with respect to work assignments and new learning
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
#J-18808-Ljbffr
Qualifications
- •Bachelor’s Degree Required
- •3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management
- •Working knowledge of VEEVA Vault
- •Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- •Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point
- •Exceptional attention to detail
- •Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills are required
- •Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
- •Highly responsive and proactive, a team player
- •Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment
- •Flexible attitude with respect to work assignments and new learning
- •Conscientious, influential person with an outstanding work ethic and strong personal discipline
Benefits
- •Work Experience 1-3 years
Responsibilities
- •The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements
- •This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials
- •Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness
- •Maintains study-specific TMF Management Plan
- •Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines
- •Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings
- •Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO)
- •Assessing outstanding issues and following through to resolution
- •Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team
- •Plan, execute, and lead study-specific meetings
- •Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies
- •Supports other trial-related operational activities as needed and assigned
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