What are the responsibilities and job description for the Senior Manager, Clinic position at LE4000 Invicro LLC?
What can we offer you?
Apart from job satisfaction, we can offer you:
HEALTH
Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA)
YOURSELF
Paid time off policy including holidays and sick time
Internal growth and development programs & trainings
WEALTH
401(k) program, life & accident insurance and disability insurance
The Senior Manager, Clinic is responsible for leading and managing the clinical research team at the New Haven Clinic to ensure the successful execution of clinical trials. This role focuses on staff management, training, quality oversight, and operational excellence, while fostering a culture of accountability, ownership, and continuous development. Reporting to the Head of Clinic and partnering with the Associate Director, Clinic, this role ensures the seamless execution of studies, maintains high-quality data standards, and enforces compliance with regulations; while inspiring and motivating the team to achieve goals, and foster a positive and productive work environment.
Key Responsibilities:
Leadership & Staff Management
- Select, hire, train, and develop a highly qualified clinical research team.
- Ensure appropriate staffing levels, aligning with clinical research demands.
- Create and oversee staff schedules to ensure efficient clinic operations.
- Supervise daily activities of the clinical research team to ensure optimal workflow.
Performance Management & Development:
- Conduct quarterly and annual employee performance reviews to provide structured feedback and encourage professional growth.
- Establish development plans for staff, identifying opportunities for advancement and skill enhancement.
- Provide real-time coaching and mentoring to support ongoing employee development.
Training & Compliance:
- Ensure all team members are properly trained in clinical research protocols, regulatory compliance, and operational procedures.
- Develop and enforce new policies and procedures, ensuring staff are aware of and adhere to changes.
- Maintain compliance with GCP, FDA, and institutional guidelines.
Clinical Operations & Study Execution:
- Oversee patient enrollment, schedules, and follow-ups to ensure timely clinical results.
- Establish and maintain strong relationships with study site personnel to facilitate research activities.
- Work closely with the Head of Clinic and the Associate Director to maintain efficient scheduling, patient flow, and resource allocation.
Quality Oversight & Regulatory Compliance:
- Ensure high-quality data collection and reporting in accordance with regulatory requirements.
- Participate in periodic quality audits and implement corrective actions as needed.
- Maintain an active role in regulatory inspections and sponsor audits.
Process Improvement & Operational Efficiency:
- Identify areas for improvement in clinic operations and implement strategies to enhance efficiency.
- Partner with the Associate Director to standardize processes and optimize workflows across shifts.
Collaboration & Stakeholder Engagement:
- Serve as the primary liaison between the clinical team, Associate Director, and Head of Department, ensuring alignment in staff allocation and clinic priorities.
- Maintain positive relationships with internal and external stakeholders, including study sponsors and regulatory agencies.
Other:
- Carryout any other reasonable duties as requested.
Functional Competencies (Technical Knowledge/Skills):
- Extensive knowledge of clinical operations and healthcare regulations.
- Proven experience in staff hiring, training, and performance management.
- Strong leadership in fostering accountability and ownership within teams.
- Expertise in clinical trial execution, patient scheduling, and follow-up tracking.
- Ability to develop and implement new policies and procedures effectively.
- Experience managing multi-center clinical research studies and translational research studies.
- Familiarity with imaging-based research (PET, SPECT, MRI) is a plus.
- Strong understanding of GCP, FDA, and other regulatory requirements.
Experience, Education, and Certifications
- Bachelor’s Degree in a related field (e.g., Clinical Research, Life Sciences, Healthcare, or a related discipline).
- Proven experience managing and leading multidisciplinary clinical research teams.
- Direct experience managing large teams in a clinical research setting.
- Previous experience overseeing clinical research studies, including multi-center and translational research.
- Experience using tools to track patient enrollment, scheduling, and follow-ups.
- Experience in staff coaching, mentoring, and development.
- Experience in creating, implementing, and communicating new policies and procedures.
English: Fluent