Manager, Cardiovascular Safety Services
Tempe, AZ
4111 - Early Clinical Research – 4111.4200 - Clinic /
Full-Time /
Hybrid
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
We are seeking a Manager of Cardiovascular Safety Services to join our team. This is an exciting opportunity to work on innovative projects, supporting critical processes within a clinical lab setting. This is a full-time role, working on-site in Tempe, AZ. We are seeking candidates who are local to the Phoenix area.
The purpose of the Manager of Cardiovascular Safety Services is oversee ECG, Holter, QTc, and cardiovascular trials, ensuring data collection, analysis, and FDA submission. Manage lab operations and serve as the primary resource for client inquiries and support.
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
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
