Senior Manager, Laboratory

Key Accountabilities:

• Manages and oversee laboratory staff day to day activities providing direct supervision, including but not limited to the following: hiring and training, performance management and performance reviews to ensure compliance with policies and regulations, maintain staff schedule and approve all timesheets
• Meets regularly with Operations Management team (and others as applicable) to proactively plan needs for upcoming studies
• Possesses thorough knowledge of all current study protocols and maintain knowledge on any changes or updates made.
• Monitors, distributes, and researches information regarding implementing changes in regulatory guidelines as well as trends and developments in techniques and technology relevant to the field
• Provide oversight of activities in the laboratory including quality assurance and safety programs.
• Perform, assist, and support functions within the laboratory as needed
• Monitor test results, equipment, and laboratory information systems
• Provides clinical input on protocols in development and assess feasibility. Identifies risks and strategies to mitigate risk and supports leading next steps with implementation.
• Evaluates proposed protocols and provides feedback to Business Operations on clinical feasibility.
• Provides Department feasibility assessments for study protocols and design when programs are being considered through Business Development.
• Provides information to Business Operations/Business Development to complete proposals/budgets as appropriate.
• Leads departmental meetings regularly as appropriate.
• Interfaces with key departments to discuss status of current studies at PAREXEL, as well as strategies for any potential challenges, including but not limit to staffing, vendor or hospital issues.
• Provides continued contact with the Sponsor for duration of the clinical study including entertaining Sponsor during site visits.
• Establishes and maintains relationships with hospital or facility representatives as appropriate.
• Reviews Draft consents and offers suggestions to Regulatory Compliance.
• Manages all aspects of departmental performance improvement strategies including identifying areas for improvement, developing action plans in conjunction with all affected areas/staff, tracking results and reporting results to upper management.
• Determines the necessity for the creation of departmental Clinical Operating Guidelines (COGs) and Standard Operating Procedures (SOPs) to meet hospital/facility requirements.
• Oversees and approves the review, revision, and/or retirement of departmental COGs and SOPs, upon approval, oversees the training and implementation of departmental and inter-departmental COGs/SOPs.
• Maintains and updates knowledge of Good Clinical Practices (GCPs)/Good Documentation Practices (GDPs) and their proper application. Reinforces the use of GCPs/GDPs departmentally through example and staff training.
• Maintain a positive, results orientated work environment, building relationships with management, colleagues, and other departments, communicating in an open, balanced, and objective manner.
• Assumes other duties and responsibilities, as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all inclusive

Skills:

• Ability to lead and motivate functional groups to be client focused, achieve Unit/project-specific objectives, and strive for continuous improvement
• Thorough knowledge of applicable international and local guidelines and regulations (e.g. ISO 9001, USP 797, GCP, GLP, GMP).
• Well-developed communication, managerial and other soft skills.
• Highly organized with the ability to manage multiple tasks of competing priorities.
• Self-motivated with a willingness to accept responsibility and challenges.
• Computer skills; ability to use MS Word, Excel, Power Point and Outlook
• Experience in dealing with confidential materials.
• Ability to effectively manage time, manage resources and multi-task.
• Ability to work a flexible schedule according to business needs

Knowledge and Experience:

• 6+ years related experience, including proven technical knowledge and laboratory experience
• 5+ years lab management and managerial experience
• Experience managing a staff (hiring, training, performance reviews, etc)
• Experience and knowledge following lab protocol
• Knowledgeable of related laboratory technology, instruments, and equipment

Education:

• BS/MS in a related science (Biology, chemistry, biochemistry, or other health related sciences)
• Advanced degree in the sciences preferred

Base Pay Range: $111,500.00 to $139,400.00 annually

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy.  Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.