Clinical Project Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary

The Clinical Project Specialist position is responsible for providing general

administrative project management support for the assigned projects.

Essential Functions

• Performs 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.
• Assists with document collection, dissemination, tracking and filling as per the organizational process ensuring compliance with SOPs and processes, and all applicable regulations.
• Assists with the development and distribution of site binders as requested.
• Tracks and prepares 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.
• Sets-up and coordinates meetings, takes and distributes meeting minutes.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Works closely with study team members and study manager to fulfill assigned study execution tasks.
• Supports study material development as assigned.
• May participate in process improvement and quality-related initiatives associated with study execution and departmental deliverables.
• Other duties as assigned.
  
  

Necessary Skills And Abilities

• 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.
• 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.
  
  

Educational Requirements

• Bachelor’s degree is preferred.
• 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.
  
  

Experience Requirements

• 2+ years of experience in the pharmaceutical/clinical research environment is preferred.
• The ideal candidate will have at least 1 year of Clinical Project Specialist experience.
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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