Associate Manager, Medical Lab (Anatomic Pathology)
- The Associate Manager of Anatomic Pathology is responsible for the daily oversight of the Anatomic Pathology functional area, specifically assuring that all testing complies with sponsors of clinical trials and external regulatory requirements. This includes but is not limited to creation of study-specific Standard Operating Procedures (SOPs), supervision of support personnel in the accessioning, documentation, transcription and resulting phases of Anatomic Pathology and actively preparing for and participating in all required audits.
- The purpose of the supervisor is to ensure that the first bullet point is met, including providing training and front line engagement when necessary, even if the needs exceed the usual workday/workweek.
Duties and Responsibilities:
- Assures the daily functioning of the division of Anatomic Pathology through supervision of support personnel
- Coordinates samples for testing, including accessioning, appropriate documentation, transcription and resulting phases of Anatomic Pathology testing; this includes the daily coordination of workload distribution to professional staff.
- Functions as the point person for divisional communications (both internal and external)
- Regularly communicates with sales and support personnel of central laboratory group in monitoring and resolving problems.
- Coordinates IT requirements, including establishing parameters needs for specific studies and assuring successful testing prior to go live.
- Creates new study-specific SOPs and assures the periodic updating of existing study SOPs
- Provides training to divisional and professional staff on study-specific SOPs within timelines defined by those SOPs.
- Prepares for and actively participates in audits performed by clinical trial sponsors and regulatory agents (e.g., FDA).
- Prepares monthly reports on workload performed for the finance department and Director.
- Assures the secure archiving of study materials and that it meets study-specific requirements
- Establishes performance development objectives for divisional employees (direct reports) and administers mid-year and annual performance reviews on those employees
- Supports the Director in forecasting and planning resource requirements for current and future studies, including analysis of manpower and material needs.
- Understands and applies the site safety, environmental policy, safety management system and relevant legal safety & environmental requirements.
- Is familiar with the safety and environmental rules and procedures applying to the role and takes reasonable care of own safety and that of other people.
- Uses the control measures and personal protective equipment provided, reports any safety related deficiencies and contribute to improving accident and safety performance.
- Complies with all applicable standards as required by the company.
- Participates in the annual performance appraisal process.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of clinical testing procedures and applicable laboratory testing regulations
- Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific
- program requirements
- Knowledge of occupational safety and health rules and regulations
- Good written and oral communication skills
- Effective supervision and coaching skills
- High ethical standards
- Ability to assess and prioritize multiple tasks, projects and demands
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in a health sciences field and 5 years relevant experience; or equivalent combination of education,
- training and experience
- ASCP Certification in QIHC (Immunohistochemistry) and HT (Histotechnology) highly preferred
EEO Minorities/Females/Protected Veterans/Disabled
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