Clinical Study Manager

PSG Global Solutions; Collegeville (PA); On-site; USD 85,000 - 100,000; Full time

Job summary

A leading recruitment agency in the United States is seeking an experienced candidate to assist with Inspection Readiness Preparation. The role involves leading diverse CRO teams through the Inspection Readiness process and ensuring extensive knowledge of clinical trial documents. The ideal candidate will have strong pTMF experience and a solid understanding of Inspection Readiness activities. This is an excellent opportunity for someone looking to advance within the pharmaceutical and biotechnology sectors.

Qualifications

• 3-5 years of relevant experience required.
• Hands-on knowledge of inspection readiness activities in clinical trials.
• Understanding of clinical study documentation and sponsor inspections.

Responsibilities

• Assist with Inspection Readiness Preparation.
• Lead diverse CRO teams through Inspection Readiness.
• Search for documents in pTMF.
• Ensure all documents are present in pTMF.
• Review Inspection Readiness checklist of ~500 items.
• Compile relevant SOPs into SharePoint.
• Assist with filing protocol amendments in pTMF and ICD updates.

Skills

pTMF

Inspection Readiness activities

Clinical Study Knowledge

Job description

At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the World's best pharmaceutical, biotechnology and medical companies.

As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.

Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.

Job Description

• 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.

Qualifications

• pTMF
• Inspection Readiness activities
• Clinical Study Knowledge

Experience:

• 3-5 years

Education:

Additional Information

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