Job Description

·       Support the day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements.

·       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.

·       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 in order to fulfill assigned study execution tasks.

·       Support study material development as assigned, and if in the senior position provide support to the junior team members.

·       As a senior clinical project specialist provide support and guidance for the junior team, including training and possible line manager responsibilities.

·       May participate in process improvement and quality-related initiatives associate with study execution and departmental deliverables

·       Other duties as assigned

Qualifications

·       Bachelor’s degree required. Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.

·       2+ years of experience in the pharmaceutical/clinical research environment. Ideal candidate will have at least 1 year of Clinical Project Specialist experience.

·       At least 5+ years of experience for the Sr. Clinical Project Specialist Role

·       Excellent communication and interpersonal skills are essential as the CPS interacts with many people of varying levels of responsibility for clinical trial programs.

·       Must be able to write clearly and summarize information effectively

·       Must have the ability to build and maintain positive relationships with management and peers.

·       Excellent verbal, written communication skills and interpersonal and presentation skills are required.

·       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 necessary

·       Electronic data capture (EDC), CTMS, IVRS, and eTMF experience is preferred

·       Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.