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Job type: Contract

Discipline: Clinical Evaluation

Location: United States

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!

�� 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.

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

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