The purpose of the Celerion ECG Core Lab is to collect ECG and Holter data from the clinics, analyze the data digitally, and send data to the FDA. The Manager will be responsible for management of thorough QTc and intensive ECG trials and other cardiovascular diagnostic tests at all of the ECR clinics. They will also be responsible for overseeing the operational management of the ECG Core Lab. This position will assume the role of a resource person to respond to client issues, concerns and requests regarding all ECG Core Lab projects.
Essential Functions
Responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
Management of ECG Core Lab
Identify, implement and track new directives for department efficiency and growth -
Delegate project tasks, as required - Monitor adherence to rules, regulations, procedures and project timelines -
Coordinate and successfully communicate project responsibilities and timelines with all support divisions and external vendors to ensure successful project execution -
Review fee proposals - Oversee logistical design and feasibility of ECG Core Lab studies -
Communicate ECG Core Lab requirements to external vendors and collaborate to develop mutually beneficial objectives -
Review, evaluate and improve the operational systems, processes and policies in support of organizational objectives and to improve operational output -
Monitor department productivity, as well as, personnel growth and advancement opportunities -
Assist in creating annual department budget -
Contribute to short and long-term organizational planning and strategy as a member of the management team
Implement software validation and rollouts by performing risk assessments, developing user requirements and playing a major role in software validation -
Coordinate with external vendors to perform software installations, software patches or root cause investigations - Coordinate with IT department to insure proper installation and function of digital ECG software, Web service interface and portal access -
Represent the ECG Core Lab and discuss cardiovascular safety services with clients during internal site visits -
Respond to client inquiries regarding operational elements and capabilities of the ECG Core Lab and other cardiovascular service offerings
Management of Clinical Studies
Perform Project Manager responsibilities, as needed -
Oversee the management of resource allocation for all ECG Core Lab studies and ECG Core Lab projects -
Ensure regular meetings are conducted to ensure the coordination and standardization of conduct among all ECG Core Lab personnel
Provide training and mentoring for all team members
Respond to client issues, concerns and requests
Assess and take action as special situations occur with ECG Core Lab projects
Study Preparation
Protocol, Specification sheet and T/E review, as needed
Ensure all studies obtain appropriate sponsor approval for ECG Core Lab studies via Study Configuration Form
Ensure software, device functionality and availability for all ECG Core Lab studies
Ensure adequate supplies on hand for conduct for all ECG Core Lab projects
Perform Project Manager responsibilities, as needed
Ensure compliance and quality
Ensure compliance with client protocol, Standard Operating Procedures and federal regulations
Oversee the creation of HL7 files and all FDA submissions Ensure all Quality Assurance audits are responded to in timely manner
Ensure all data management edit checks are responded to in a timely manner
• Bachelor’s degree in Life Sciences or related filed required
• Excellent computer skills and proficient in excel, word, outlook, and access
• Excellent communication skills both verbal and written
• Demonstrated leadership and vision in managing staff groups and major projects or initiatives
• Excellent interpersonal skills and a collaborative management style
• Ability to challenge and debate issues of importance to the organization
• Proven organizational and multi-tasking ability
• Proven negotiation skills
• Conflict Management
• Minimum of 3 year ECG Core Lab Project Management experience preferred
• Ability to manage multiple priorities
• Excellent leadership skills with ability to influence and lead in a team environment
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