Project Manager

Essential Functions:

• Responsible for staff management including 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

• Oversee resource allocation, team coordination, and standardization for all ECG
• Core Lab projects. Provide training, mentorship, and client support.
• Handle special project situations and perform Project Manager duties as needed.

Study Preparation

• Review protocols, specifications, and T/E as needed.
• Secure sponsor approval via Study Configuration Form.
• Ensure software, devices, and supplies are ready for all ECG Core Lab studies.
• Perform Project Manager duties when required.

Compliance & Quality

• Ensure adherence to protocols, SOPs, and regulations.
• Oversee HL7 file creation, FDA submissions, and timely responses to QA audits and data edit checks.

Qualifications:

• Bachelor’s degree in Life Sciences or related field 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 years ECG Core Lab Project Management experience preferred
• Ability to manage multiple priorities
• Excellent leadership skills with the ability to influence and lead in a team environment
• Flexibility of hours required