Position: Full Time

Location: Newtown, PA (in-house)

Responsible for the overall relationship management of client accounts, ensuring that the company is able to deliver quality projects and services on time and within budget through the effective management of company resources.

Duties and Responsibilities

• Serves as the primary point of contact with the Sponsor for assigned projects to ensure appropriate communication channels are maintained and reporting schedules are adhered to

• Coordinates and manages clinical trials from start-up to closeout

• Liaises with internal departments to ensure adequate resources are available

• Manages study objectives and budgets of assigned projects

• Requests and manages project change orders on an as-needed basis

• Assists in the development and review of sponsor cost estimates and proposals

• Attends bid defenses, investigator meetings, and other client meetings as needed

• Tracks and maintains project management system

• Evaluates the probability and impact of risks, develops plans for minimizing impact on project objectives and implements improvement processes for assigned projects

• Participates in departmental policy/procedure development and modification

• Oversees invoicing authorization of work completed for the client

• Oversees and coordinates all project timelines and deliverables for each assigned project

• Assures compliance with Company’s standard operating procedures and work practices

• Manages third party vendors when requested

• Works with Business Development Team to ensure customer satisfaction and effective scope of work as required for project life cycle

• Represents the company at meetings and on conference calls with prospective clients

Minimum Requirements

• Minimum 5+ years of experience in the CRO (preferred) or pharmaceutical/biotech industry

• Familiar with the clinical development of both pharmaceuticals/biologics and devices

• Experience in a project management role with US and global, single or multi-center pharmaceutical and device studies

• Capable of managing multiple projects simultaneously

• Excellent organization, communication, and management skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

• Knowledgeable in GCP, ethics and CFR 21 Part 11 compliance in clinical trials

• Experience in computer applications including Word, Excel, PowerPoint, and SharePoint

• Minimal travel required (approximately 20%)

• Bending and lifting up to 20 pounds