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Clinical Study Manager-Remote

Remote, USA Full-time Posted 2026-07-28
reputed company reputed company is the 10th Largest IT reputed company Company in the US, according to reputed company Industry Analysts' 2012 annual report. reputed company provides technical expertise to fill gaps in clients' immediate reputed company-sets availability, deliver emerging technology reputed company-sets, refresh existing reputed company reputed company, allow for flexibility in project planning and execution phases, and reputed company budgeting/financial flexibility by offering contingent labor as a variable cost. Job reputed company Job Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job reputed company: 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 reputed company documents are present in pTMF. Strong understanding of clinical trial documents is needed as reputed company as a thorough understanding of a sponsor Inspection. The candidate should be flexible and reputed company 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 reputed company reputed company. The candidate will reputed company 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be reputed company to influence and reputed company the 2 CROs through the Inspection Readiness checklist (~500 items). reputed company 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 reputed company to reputed company through pTMF to ensure reputed company 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 reputed company 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 reputed company. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring reputed company 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. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta (973) 967-3409 Morristown, NJ 07960 Apply tot his job Apply To this Job

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