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
\n Management of Clinical StudiesResponsible for managing and coordinating the ECG Core Lab studies and projects among all ECG Core Lab Project ManagersManage resource procurement and allocation for all ECG Core Lab studiesHold regular meetings to coordinate and standardize conduct among all ECG Core Lab Project ManagersProvide 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 daysAssess and take action as special situations occur in study conductTake on additional assignments as needed Study Preparation 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 and QualityEnsure 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 ValidationPerform 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 Clinical ConductRecord raw data Collect 12 lead ECGs Collect Holter Recordings*Conduct other reasonable duties as assigned
Knowledge/Skills/Education/Licenses** 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)**Equivalent education and experience will be considered.
\nCelerion 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.