Clinical Manager

The Clinical department conducts human clinical safety and claim substantiation/efficacy studies for cosmetics/personal care products, topical and ophthalmic drug products.

• The position will be responsible for:
• Set up the planning, development and implementation of study protocols, logistical procedures, and operating systems for the clinical team.
• Generate study protocols and review/approve the interim reports, and final reports for study sponsors.
• Sign study protocols as the Principal Investigator or sub-investigator.
• Supervises, evaluates, and coordinates the activities of a team of Clinical Research Coordinators and ensures that all clinical activities are carried out in accordance with Company SOP’s and guidelines of Good Clinical Practices.
• Oversees the planning, scheduling and carrying out of day-to-day clinical activities, maximizing on study workflow, and associated availability of research subjects.
• Works closely with Recruitment Department ensuring study specific subjects are recruited and enrolled in a timely manner prior to study conduct.
• Monitors study subjects’ response to treatment and communicates study data and results to investigators in a timely manner.
• Assists and/or conducts pilot studies to validate experimental procedures with minimum guidance.
• Oversee QA/QC operation of the department to ensure compliance to regulations and processes.
• Creates and monitors clearly defined quality methods for staff to apply. Defines quality procedures in conjunction with operating staff.
• Maintains and controls documentation procedures. Identifies relevant quality-related training needs and delivering training ensuring tests and procedures are properly understood, carried out and evaluated.
• Ensures consistency and quality of site monitoring visits, which may include conduct of periodic co-monitoring visits with CRAs and/or training and supervision of co-monitors
• Customer service and follow-up (discuss methodologies/protocols)
• Ensures that staff is adequately trained and documentation is in place on clinical practices including bioinstrumentation, and other clinical safety and efficacy procedures.
• Management of the team of researchers and technicians involved in the most complex studies
• Employee morale – “Open Door” discussions, mediation, buffering, brokering compromise, maintaining focus on enterprise success.
• Communication of performance standards and expectations.
• Develops, maintains and promotes positive, effective and collaborative working relationships with and among internal team members and as applicable, with external CRO and 3rd party vendor personnel and co-development partner study teams.
• Collaborates with other study Team members to ensure consistency and efficiencies across the study Team, and other in-house teams as assigned.
• Develops Strategies to improve productivity in Clinical Testing Lab.
• Monitors Study Cordinators and identifies areas for improvement.
• Collaborates with General Manager of growth plans in all clinical areas.
• Prepares yearly budgets and monitors monthly KPI in lab.
• Other tasks as required or assigned (which may include working after hours or weekends).

• Master’s Degree in a scientific discipline at least 2 years of relevant work experience.
• Direct experience in clinical trial development
• Excellent written and verbal communications skills.
• Experience at supervising/managing subordinates.
• Detail oriented, flexible, multi-task oriented proficient with Microsoft Office software suite.
• Exceptional Interpersonal skills.
• Proficiency in interpreting clinical data.
• Familiarity with statistical software a plus.
• Excellent organizational skills.

• Health Coverage: Medical, Dental, and Vision
• Retirement Plan: 401(k) and Roth contributions with a company match after 6 months of employment
• Paid Time Off, Vacation
• Company paid Life Insurance
• Company paid Short Term and Long Term Disability
• Other: Ancillary benefits