Job Description

Clinical Study Specialist - Contract - Basking Ridge, NJ

Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!

Proclinical is seeking a Clinical Study Specialist for a hybrid role based in the US. The Clinical Study Specialist provides technical and administrative support to the clinical study teams responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program.

Primary Responsibilities:

The successful candidate will receive assignments from the Clinical Study Lead or Clinical Study Associate Manager. They will be responsible for supporting both internally managed studies and those outsourced to Clinical Research Organizations (CROs).

In this role, a typical day might include the following:

• Organizes and delivers analyzable reports and metrics to the clinical study lead
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Prepare data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
• Prepares and compiles materials for training sessions and investigator meetings
• Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form)
• Manages and maintains team SharePoint and/or shared drive sites, as needed
• Communication with sites as directed and maintains site contact information
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• May manage or contribute to oversight of Third-Party Vendors (TPV)
• Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department

This role might be for you if:

• You have strong attention to details for the ability to track information and deliver on assigned study activities
• You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally
• You are resourceful and demonstrate problem solving skills
• You can proactively assess information and investigate impact on clinical trials

To be considered, a bachelor's degree with 2+ years of relevant pharmaceutical industry experience. In lieu of a bachelor's degree 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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