Manager, Clinical Studies Lab Implementation

• Maintain open and effective communication with the work team and with members of other associated teams. Develop, lead, and mentor a team of associates.
• Work collaboratively with Medical Directors and Clinical Laboratory Directors on the clinical studies within the laboratory.
• Interface with laboratory and processing staff and department leaders to facilitate the processing of study samples and new test system samples according to design.
• Prepare materials for communicating the clinical study laboratory roadmap, clinical study sample processing, and monitoring framework in conjunction with Leadership.
• Manage complex, cross-functional projects with a good knowledge of clinical laboratory regulations and guidelines.
• Coordinate clinical study timelines with program management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.
• Lead preparation of requirements and project scope; effectively manage interactions with internal and external clients.
• Implement sample processing changes and demonstrate adaptability by embracing changes in the laboratory with a positive attitude.
• Provide technical support in developing, optimizing, and implementing study samples, test methods, and test systems.
• Field technical questions about studies or test methods and systems and connect to teams to help resolve.
• Participate and attend meetings and activities to develop, optimize, and implement new test methods and test systems.
• Capture and articulate laboratory need for supporting clinical trial studies and new test methods and systems.
• Demonstrate professional demeanor, in personal appearance and behavior, in all work-related interactions inside and outside of the laboratory.
• Manage projects associated with the clinical study plans and operations of the Clinical Study Team.
• Mentor, train, and work with the team members and other associated teams; deliver continuous improvement feedback and support related to clinical trial samples.
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Strong problem-solving skills with the ability to anticipate problems, diagnose root causes, and take corrective action to prevent reoccurrence.
• Complies with all safety and hazard regulations as outlined in the Clinical Laboratory Safety Manual and ensures that all employees follow laboratory and regulatory guidelines. Understands, maintains and enforces safety guidelines.
• Comply with the Exact Sciences’ Labs record retention policy, maintain accurate training recording, and ongoing competency evaluations.
• Comply, assist, and support the development, maintenance, data collection, quality control (QC) and quality analysis (QA) programs analysis.
• Support and comply with the Company’s Quality Management System policies and procedures.
• Take part in department projects and initiatives; including, but not limited to, quality improvement teams (QIT) and quality improvements investigations, such as root cause analysis (RCA), standard operating procedure (SOP) development, department inspections, and audits.
• Ability to respond to stakeholder requests in a professional and timely manner.
• Ability to work cross-functionally and communicate effectively at all levels of the organization.
• Ability to work independently when fielding inquiries from other departments.
• Exceptional written and verbal English communication skills and presentation skills.
• Strong attention to detail.
• Strong technical problem-solving skills to anticipate problems, diagnose root causes, and take corrective action to prevent reoccurrence.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• The position requires regular and reliable attendance and work in a normal laboratory environment. Special uniform and personal protective equipment are required while working in the laboratory.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability to travel 5% of the working time away from the work location may include overnight/weekend travel.

• Bachelor’s degree in clinical laboratory science, chemical or biological sciences, or field related to essential duties of job.
• 4+ years of experience working in a clinical laboratory setting with an emphasis on Molecular techniques, Next Generation Sequencing, and Histology.
• 3+ years of supervisory experience.
• 1+ years of experience with human subject research.
• Demonstrated knowledge of Health Insurance Portability and Accountability Act (HIPAA), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Documentation Practices (GDP).
• Knowledge of CAP, CLIA, NY and HIPPA rules and regulations.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• 3+ years of clinical trial/clinical study experience.
• 2+ years of experience in training others on laboratory processes.

Exact Sciences Corporation