Clinical Project Director

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

We are currently recruiting for a Clinical Project Director to join our team in North America.

The Project Director (PD) coordinates and oversees operational project teams, customer satisfaction and continuous improvement of processes within the Clinical Trial Operations (CTO) department. This position controls and monitors the quality and full-service delivery of clinical trial project management activities - all with the sense of urgency expected of Allucent customers.

Location: North America

Responsibilities:

Project oversight:

• Responsible for overall quality and management of the delivery clinical trial projects and programs
• Manages complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery
• Oversees budgets and ensuring correct financial forecasting, planning, invoicing and timely implementation of out of scope activities
• Reviews and approves content and costing of proposals
• Ensures effective risk management across the project delivery lifecycle
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
• Balances multiple competing priorities, with effective and efficient resource utilization across projects and programs

Client management:

• Serves as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs

Leadership:

• Shows knowledge of and insight into general business principles and practices, and is able to balance business priorities
• Demonstrates a growth mindset, and approaches complex challenges with creativity and flexibility
• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Supports the recruitment and interviewing of new employees
• Responsible for supervision of project staff and communication with functional managers, including performance feedback
• May be assigned as line manager

Management, Learning & Development

Actively supports staff learning & development within the company

Quality Management

Drafts and contributes as Subject Matter Expert (SME) in the field of global clinical trial delivery activities to the evaluation/improvement of processes and procedures within the Quality Management System

Account Management, Sales & Acquisition

• Ensures good communication and relationships with current and future clients
• Able to identify client needs and new business opportunities
• Capable of translating protocol requirements into a clear operational strategy for client engagements
• Able to translate guidelines, rules and regulations into clear and usable recommendations
• Actively contributes and participates in client evaluations, visits and bid defenses
• Networks with local and national agencies for future project development in cooperation with other departments

Other

• Contributes to other areas of the Allucent business as required
• Business travel is required for this position, including possible international travel

Requirements

Qualifications

• Minimum Bachelor’s degree in life science, healthcare and/or business degree; Master’s degree or greater preferred
• Minimum 7 years of relevant work experience
• Minimum 7 years of experience in drug development and/or clinical research
• Extensive clinical project management experience, with at least 5 years of clinical project management experience
• Preference for candidates with CRA experience
• Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
• Strong financial acumen, administrative excellence and analytical skills
• Experience managing global clinical trials

Skills

• Exce