Assoc Dir, CTM Production team

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview
Direct or provide directional support to the planning, development and implementation of clinical trials materials processes and procedures. Provide clinical trials materials related regulatory expertise and guidance and strategic direction to staff, internal and external customers.

Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Essential Functions
• Support strategic direction for global clinical trials materials
• Execute or ensure strategic initiatives are executed in a timely manner in accordance with the project plan
• Manage allocation of clinical trials materials resource, including project initiatives / assignments
• Provide operational liaison between departments as needed
• Plan, coordinate, and provide leadership for clinical trials materials projects
• Develop and maintain good communications and working relationships with internal and external clients, regulatory agencies, couriers and related companies
• Maintain and adhere to standard operating procedures (SOPs) related to clinical trials materials, related regulations, and training
• Keep abreast of current data, trends, regulations, developments, and advances in area of expertise
• Serve as regulatory consultant for internal and external clients and global QLABs
• Develop or support new processes to improve clinical trials materials operations within the company
• Develop, revise and maintain current practices, policies and procedures to support both the department and internal / external customers
• Manage staff in accordance with organization’s policies and applicable regulations
• Responsibilities include planning, assigning, and directing work
• appraising performance and guiding professional development
• rewarding and disciplining employees
• addressing employee relations issues and resolving problems
• Approve actions on human resources matters

Qualifications
• Bachelor's Degree
• 6 years relevant experience including 3 years experience in a leadership capacity and/or equivalent combination of education, training and experience.
• Comprehensive knowledge of clinical trials materials procedures.
• Effective organizational and interpersonal skills.
• Effective communication skills and strong presentation skills.
• Skill extracting relevant data to measure performance indicators and proactively plan for growth and scalability.
• Ability to lead and motivate high-performing teams.
• Ability to analyze work processes to drive efficiency and scalability.
• Ability to manage multiple projects and ensure that they are performed in a quality manner.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Good working knowledge of lab procedures.
• Strong organizational and problem-solving skills.
• Ability to effectively delegate work.
• Ability to effectively manage multiple tasks and projects, and direct team members.