eTMF Scanning OperatorDuration:
East Hanovar, New Jersey Process / Department Details:
Clinical Document Management Roles and Responsibilities
JOB SPECIFICATION - Required Educational Attainments (Degrees, Certificates etc)
- From Indexing System and repository system, retrieve paper and electronic clinical documents for complex business, legal and regulatory or audit purposes
- Perform Quality Check on every paper document retrieved as per work process and instruction guide.
- If documents not present in the Repository System, scan those as per the scanning guidelines/SOP
- Split the document if required or use separators.
- Save documents by providing naming conventions as per regulatory guidelines- naming convention guidelines.
- Perform Quality Check on the electronic copy to ensure conformity with paper document
- Maintain the findings in tracker.
- Coordinate with offsite team. Provide details of documents mentioned in tracker for importing them in CREDI.
- File the paper document back in the relevant indexing structure/archive location.
High school diploma or Degree in related area (e.g. library science, information technology) or
Equivalent or a science degree Required Skill Sets (Technical/Behavioral)
Required Attributes (Vision, Strength, Personality Trait, Certain Aptitude)
- Knowledge of the clinical drug development and international drug approval processes and related document requirements.
- Knowledge on Trial Master Files document types, definition and related regulations
- Good organizational skills and significant project work or project management experience
- At least 06 months to 1 year of relevant experiences in managing, archiving, retrieving or compiling clinical documents
Required Experience (of what type, for what duration, what industry/background)
- Achievement driven
- Excellent written and verbal English communication skills
- Detail focused
- Ability to prioritize, schedule and organize
- Excellent interpersonal
At least 6 months to 1 year of relevant clinical research/ pharmaceutical industry experiences. Additional and Special Requirements
Valid working visa for USA Best regards, Nelson White
Sr. IT Recruiter | Talent Acquisition TeamE-mail:- Nelson@conq-tech.com
302-357-9147Conquest Tech Solutions
19 C Trolley Square, Wilmington, DE – 19806Office:
(302) 357-9017 | Fax: