Project Manager – Clinical Research – Entry-Level
| Company | Celerion |
|---|---|
| Location | Tempe, AZ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Entry Level/New Grad |
Requirements
- 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)
Responsibilities
- 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
- 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
Preferred Qualifications
- Equivalent education and experience will be considered.