Position: Full Time
Location: Newtown, PA (some travel)
Direct and manage Company projects and responsible for overall relationship management of client accounts ensuring that the Company is able to deliver quality projects and services on time and within budget through effective management of company resources.
To operate and ensure the highest level of ethics in the management of the trial and in corporate responsibility.
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
- Be pro-active in the management of the studies
- 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
- Track and maintain project management system
- Evaluate the probability and impact of risks, develop plans for minimizing impact on project objectives and implement improvement processes for assigned projects
- Participate in departmental policy/procedure development and modification
- Oversee invoicing authorization of work completed for the client
- Oversee and coordinate all project timelines and deliverables for a sponsoring client
- Manage 3rd party vendors
- Team with sales organization to ensure customer satisfaction, effective scope management and change management as required for project life cycle
- Represent the company at meetings and on conference calls with excellence.
- Minimum of 5+ years of experience in the CRO or pharmaceutical industry
- Experience in a project management role with global, multi-center studies
- CRO experience preferred
- Imaging or oncology experience preferred
- Excellent organizational, communication and management skills
- Good inter-personnel skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients in a matrix organization
- Knowledgeable in GCP, ethics and CFR 21 Part 11 compliance in clinical trials
- Experience in computer applications including Word, Excel, PowerPoint, SharePoint
- Minimal (approximately 20%) travel required
- Bending and lifting up to 20 lbs.