Requisition ID 14595BR
Title Clinical Documentation Specialist, Clinical Data Management
Job Category Clinical
Job Description PURPOSE:
The Clinical Documentation Specialist is the point person in Clinical Data Management (DM) responsible for the processing and compilation of the clinical trial data related documents (eCRFs and pCRFs) for regulatory submissions. This position establishes and enforces timelines for processing and ensures the quality & accuracy of clinical trial data related documents.
RELATIONSHIPS:
This position reports to line of business (LoB) manager in the CTM DM Department. The Clinical Documentation Specialist interacts with the members of Clinical Trial Management (CTM), Medical Writers (MW), ePublishers in NNI and NN A/S, and Clinical Documentation Specialist in Data Management unit in India. Serves as a primary contact and information resource regarding clinical trial data related documents within DM.
ESSENTIAL FUNCTIONS:
CRF DOCUMENTATION PROCESSING:
- Coordinates with Clinical Trial Archiving Group to retrieve electronic and paper CRFs.
- Scans CRFs and Export files to a secured drive for Data entry and further data processing.
- Tracks CRFs after batch scanning, records any discrepancies into CRF tracking tool and report to assigned Clinical data manager.
- Utilizes CRF Track system to process CRF documents to be included in published CTRs by compiling pages electronically, adding hyper-links, and converting CRFs to pdf files for indexing in novoDOCS.
- Inspects site patient data archive CDs/DVDs from EDC trials to ensure accessibility of each CD/DVD before forwarding to ITM/RTM/LTM for sending to sites.
- Inspects sponsor patient data archive hard drive from EDC trials to ensure accessibility. Remove password and import each patient’s data file into NovoDoc.
- Performs merging, indexing, bookmarking, adding hyper-linking, and quality control activities necessary to ensure accuracy of eCRFs and pCRFs being used in CTR.
CRF TRACK SYSTEM UTILIZATION:
- Coordinates with Clinical Data Manager to create new trials or modify existing trials in CRF Track, and create necessary system Table of Contents (TOC) to facilitate indexing CRF pages.
- Prepares relevant reports and work with Clinical Data Manager / Trial Manager to reconcile any missing CRF pages.
- Collaborates with NNI IT and acts as the point contact to assist local issues and / or validation testing. Identifies potential issues and suggests plans for possible changes.
QUALITY CONTROL & REGULATORY COMPLIANCE:
- Assists in periodically reviewing and revising relevant procedures and standard operating procedures (SOPs) with respect to their efficiency, workflow, and implementation affecting CRF processes.
- Performs quality checks on patient CRFs to ensure all files are ready to be used in CTR for submission to regulatory authorities.
- Performs quality checks on clinical data management documentations to ensure they fulfill requirements of Good Documentation Practice.
RELATIONSHIP MANAGEMENT:
- Super user of the novoDOCs documentation management system: provides novoDOCS training to colleagues in Data Management as well as in Clinical Trial Management when necessary.
- Work with NN A/S and other affiliates to standardize CRF processes to improve quality and speed.
- Ad hoc projects including technology related and other projects as needed.
- Provides relevant and timely feedback to Trial Manager, Clinical Data Manager regarding any process changes or improvements and works together with other individuals in CTM to provide appropriate feedback. Strives to provide exceptional customer service to customers through effective communication and proactively meeting their needs.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures.
PHYSICAL REQUIREMENTS:
- Office Based in Princeton, NJ.
- Approximately 0-5% overnight travel required.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelor’s Degree or equivalent experience required with a minimum of four years of related clinical documentation experience.
- Current understanding of FDA, ICH and other appropriate regulations pertaining to electronic documentation requirements desirable.
- Demonstrates superior interpersonal skills and strong commitment to internal/external customer responsiveness.
- Experience in Adobe Acrobat highly preferred.
- Proficiency in computer skills including MS Office and proven ability to learn additional software as required.
- Thorough understanding of clinical publishing, clinical documentation and novoDOCS technology.
Department CMR - CLINICAL DATA MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%
Title Clinical Documentation Specialist, Clinical Data Management
Job Category Clinical
Job Description PURPOSE:
The Clinical Documentation Specialist is the point person in Clinical Data Management (DM) responsible for the processing and compilation of the clinical trial data related documents (eCRFs and pCRFs) for regulatory submissions. This position establishes and enforces timelines for processing and ensures the quality & accuracy of clinical trial data related documents.
RELATIONSHIPS:
This position reports to line of business (LoB) manager in the CTM DM Department. The Clinical Documentation Specialist interacts with the members of Clinical Trial Management (CTM), Medical Writers (MW), ePublishers in NNI and NN A/S, and Clinical Documentation Specialist in Data Management unit in India. Serves as a primary contact and information resource regarding clinical trial data related documents within DM.
ESSENTIAL FUNCTIONS:
CRF DOCUMENTATION PROCESSING:
- Coordinates with Clinical Trial Archiving Group to retrieve electronic and paper CRFs.
- Scans CRFs and Export files to a secured drive for Data entry and further data processing.
- Tracks CRFs after batch scanning, records any discrepancies into CRF tracking tool and report to assigned Clinical data manager.
- Utilizes CRF Track system to process CRF documents to be included in published CTRs by compiling pages electronically, adding hyper-links, and converting CRFs to pdf files for indexing in novoDOCS.
- Inspects site patient data archive CDs/DVDs from EDC trials to ensure accessibility of each CD/DVD before forwarding to ITM/RTM/LTM for sending to sites.
- Inspects sponsor patient data archive hard drive from EDC trials to ensure accessibility. Remove password and import each patient’s data file into NovoDoc.
- Performs merging, indexing, bookmarking, adding hyper-linking, and quality control activities necessary to ensure accuracy of eCRFs and pCRFs being used in CTR.
CRF TRACK SYSTEM UTILIZATION:
- Coordinates with Clinical Data Manager to create new trials or modify existing trials in CRF Track, and create necessary system Table of Contents (TOC) to facilitate indexing CRF pages.
- Prepares relevant reports and work with Clinical Data Manager / Trial Manager to reconcile any missing CRF pages.
- Collaborates with NNI IT and acts as the point contact to assist local issues and / or validation testing. Identifies potential issues and suggests plans for possible changes.
QUALITY CONTROL & REGULATORY COMPLIANCE:
- Assists in periodically reviewing and revising relevant procedures and standard operating procedures (SOPs) with respect to their efficiency, workflow, and implementation affecting CRF processes.
- Performs quality checks on patient CRFs to ensure all files are ready to be used in CTR for submission to regulatory authorities.
- Performs quality checks on clinical data management documentations to ensure they fulfill requirements of Good Documentation Practice.
RELATIONSHIP MANAGEMENT:
- Super user of the novoDOCs documentation management system: provides novoDOCS training to colleagues in Data Management as well as in Clinical Trial Management when necessary.
- Work with NN A/S and other affiliates to standardize CRF processes to improve quality and speed.
- Ad hoc projects including technology related and other projects as needed.
- Provides relevant and timely feedback to Trial Manager, Clinical Data Manager regarding any process changes or improvements and works together with other individuals in CTM to provide appropriate feedback. Strives to provide exceptional customer service to customers through effective communication and proactively meeting their needs.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures.
PHYSICAL REQUIREMENTS:
- Office Based in Princeton, NJ.
- Approximately 0-5% overnight travel required.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelor’s Degree or equivalent experience required with a minimum of four years of related clinical documentation experience.
- Current understanding of FDA, ICH and other appropriate regulations pertaining to electronic documentation requirements desirable.
- Demonstrates superior interpersonal skills and strong commitment to internal/external customer responsiveness.
- Experience in Adobe Acrobat highly preferred.
- Proficiency in computer skills including MS Office and proven ability to learn additional software as required.
- Thorough understanding of clinical publishing, clinical documentation and novoDOCS technology.
Department CMR - CLINICAL DATA MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%