Clinical Study Manager

• This position is needed to assist with Inspection Readiness Prepartion.
• The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process.
• Strong pTMF experience is also desired.
• A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF.
• Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection.
• The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business.
• The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis.
• The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission.
• The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items).
• All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist.
• The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder.
• The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans.
• The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space.
• The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions.
• The candidate will need to work with the 2 CROs for any corrections or updates needed.

• pTMF
• Inspection Readiness activities
• Clinical Study Knowledge

Experience:

• 3-5 years
  

Education:

• Bachelors Degree

All your information will be kept confidential according to EEO guidelines.

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.

If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!