Project Manager, Cardiovascular Safety Services

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.  

The purpose of the Celerion ECG Core Lab is to collect continuous Holter data, extract and analyze the data digitally, and send data to the FDA. The Project Manager will be responsible for management of the ECG Core Lab portion of clinical studies, as well as additional assigned projects which may include software validation and other initiatives designed to increase efficiency and/or facilitate the growth of the core lab. The Project Manager will assume the role of an operational resource to respond to client issues, concerns and requests and will serve as a primary contact for all assigned projects.

Essential Functions

May be 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

• Responsible for managing and coordinating the ECG Core Lab studies and projects among all ECG Core Lab Project Managers
• Manage resource procurement and allocation for all ECG Core Lab studies
• Hold regular meetings to coordinate and standardize conduct among all ECG Core Lab Project Managers
• Provide Manager, Cardiovascular Safety Services weekly status report, either in writing or in regular meetings
•  Provide training and mentoring for new Project Managers
•  Attend client calls to provide updates throughout study
•  Be present at critical events and dosings
•  Respond to client issues, concerns and requests
•  Oversee study logistics and personnel on Holter conduct days
• Assess and take action as special situations occur in study conduct
• Take on additional assignments as needed

•  Protocol, Specification sheet and T/E review
•  Create and obtain appropriate sponsor approval for Study Configuration Form
•  Ensure software and device functionality and availability
•  Assign duties to ECG Technicians
•  Prepare and ensure appropriate equipment preparation and availability in conduct areas.
• Ensure adequate supplies on hand for conduct
•  GI license management
•  GI database creation
•  TP database creation
•  GI database configuration and verification
•  TP database configuration and verification

• Ensure compliance with client protocol, Standard Operating Procedures and federal regulations
•  Create HL7 files and prepare for FDA submission
•  Oversee all FDA Data Submissions
•  Perform quality verification of HL7 files in a timely manner
•  Respond to Quality Assurance audits in timely manner
•  Respond to data management edit checks in a timely manner

• Perform risk assessments with assistance
•  Develop User Requirements with assistance
•  Work with external vendors and IT to coordinate software and server installs
•  Patch test execution
•  Write run test cases for internal/external core lab software
•  Upload and retrieve documents from SharePoint

• Record raw data
•  Collect 12 lead ECGs
•  Collect Holter Recordings

•  Bachelor’s degree with industry experience preferred.
•  Proven organizational skills
•  Proven multitasking ability
•  1 year ECG Core Lab experience preferred
•  1 year Project Management experience preferred
•  Ability to manage multiple priorities
•  Highly accurate documentation skills
•  Ability to work without close supervision
•  Strong customer service skills
•  Strong leadership skills
•  Planning and scheduling skills
•  Ability to work in a team environment
•  Flexibility of hours required
•  Strong communication and organizational skills
•  Strong computer skills (core lab specific software, ClinQuick, Excel, and Outlook)

Celerion Values:       Integrity   Trust   Teamwork   Respect

Are you ready to join our team?

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.