Auftragsdetails

Detailed Description

The Clinical Project Specialist provides general administrative project management support for the assigned projects. This is a full time role and can be offered on a remote basis.

Essential Functions:

• Perform general administrative tasks to support project management activities related to the clinical trial execution, e.g., assist with the development and formatting of documents, review, and reconciliation of study-specific information, etc.
• Supports the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.
• Assist with document collection, dissemination, tracking and filling as per the organizational process ensuring compliance with SOPs and processes, and all applicable regulations.
• Assist with the development and distribution of site binders as requested.
• Track and prepare study-specific information utilizing databases, spreadsheets, and other tools as assigned. This may include but is not limited to clinical and non-clinical supplies and services such as tracking of appropriate subjects and site activity/metrics, performing quality check activities across different components of the clinical trial.
• Set-up and coordinate meetings, take and distribute meeting minutes.
• Proactively identify and escalate issues that arise relate to support functional deliverables.
• Work closely with study team members and study manger to fulfill assigned study execution tasks.
• Support study material development
• Participate in process improvement and quality-related initiatives associate with study execution and departmental deliverables.

Qualified candidates will have:

• Experience within a pharmaceutical/clinical research environment - ideally with experience as a Clinical Project Specialist
• Excellent communication and interpersonal skills as the CPS interacts with many people of varying levels of responsibility for clinical trial programs.
• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.
• Experience with email and calendar programs
• Electronic data capture (EDC), CTMS, IVRS, and eTMF experience is preferred.
• Relevant Bachelor’s degree is preferred.