Demand ID: 522492
Title: eTMF Scanning Operator
Duration: 6 Months
Location: East Hanovar, New Jersey
Note: we need 10 consultants for this position
Process / Department Details:
• Clinical Document Management
Roles and Responsibilities
1. From Indexing System and repository system, retrieve paper and electronic clinical documents for complex business, legal and regulatory or audit purposes
2. Perform Quality Check on every paper document retrieved as per work process and instruction guide.
3. If documents not present in the Repository System, scan those as per the scanning guidelines/SOP
4. Split the document if required or use separators.
5. Save documents by providing naming conventions as per regulatory guidelines- naming convention guidelines.
6. Perform Quality Check on the electronic copy to ensure conformity with paper document
7. Maintain the findings in tracker.
8. Coordinate with offsite team. Provide details of documents mentioned in tracker for importing them in CREDI.
9. File the paper document back in the relevant indexing structure/archive location.
JOB SPECIFICATION -
Required Educational Attainments (Degrees, Certificates etc)
1. High school diploma or Degree in related area (e.g. library science, information technology) or equivalent or science degree
Required Skill Sets (Technical/Behavioral)
1. Knowledge of the clinical drug development and international drug approval processes and related document requirements.
2. Knowledge on Trial Master Files document types, definition and related regulations
3. Good organizational skills and significant project work or project management experience
4. At least 06 months to 1 year of relevant experiences in managing, archiving, retrieving or compiling clinical documents
Required Attributes (Vision, Strength, Personality Trait, Certain Aptitude)
2. Achievement driven
3. Excellent written and verbal English communication skills
4. Detail focused
5. Ability to prioritize, schedule and organize
6. Excellent interpersonal
Required Experience (of what type, for what duration, what industry/background)
1. At least 6 months to 1 year of relevant clinical research/ pharmaceutical industry experiences.
Additional and Special Requirements
1. Valid working visa for USA