The Clinical Study Specialist provides technical and administrative support to the clinical study team responsible for clinical trial execution. They may be assigned to support multiple studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager.
Key Responsibilities
* Organize and deliver reports and metrics to the clinical study lead.
* Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings.
* Collate data for assessments such as feasibility and site selection and review site usability database.
* Contribute to the review of study documents such as informed consent forms, case report forms, and facilitate study document reviews per company standard operating procedures.
* Compile study manuals including study reference binders and manuals, and maintain versioning of study reference materials.
* Collate materials for training and investigator meetings.
* Track site activation, enrollment, and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from the monitoring plan.
* Monitor and update investigator/site status for the trial, and support with clinical trial registry postings.
* Perform scheduled reconciliations of the study Trial Master File (TMF) with clinical study lead guidance.
* Ensure scheduled reports are received.
* Manage and maintain team SharePoint and/or shared drive sites, as needed.
* Communicate with sites as directed and maintain site contact information.
* Contribute to line listings review for Blind Data Review Meeting (BDRM).
* Manage or contribute to oversight of Third-Party Vendors (TPV).
* Track and monitor close-out activities.
Requirements
* A strong attention to detail for tracking information and delivering on assigned study activities.
* Strong communication and interpersonal skills; ability to form relationships internally and externally.
* Resourcefulness and problem-solving skills.
* Ability to proactively assess information and investigate its impact on clinical trials.
Education and Experience
A Bachelor's degree with 2+ years of relevant pharmaceutical industry experience, or in lieu of a Bachelor's degree, 5+ years of relevant pharmaceutical industry experience with a focus in clinical operations or trial management.