Cardiac Clinical Operations Study Manager
Full Time/Permanent-INDIANAPOLIS, INDIANA
The Clinical Operations Study Manager will drive the overall development of the Cardiac clinical/technical study design in conjunction with the project team. The position will be accountable for study conduct including study planning, startup and execution; report writing and delivery; and study close out.
Responsibilities of Cardiac Clinical Operations Study Manager Include:
- Ensuring the study design meets US requirements for FDA clearance/approval, and/or EU requirements for CE approval
- Planning and executing to the timeline and budget
- Assigning and ensuring delivery of specific tasks to/from other members of the Clinical Operations study team.
- Providing direction and oversight to external support.
- Ensuring that studies adhere to FDA regulations, Good Clinical Practices and IVD directives.
- Maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Travel is required for this Cardiac Clinical Operations Study Manager position
JOB REQUIREMENTS:
- Bachelor of Science degree in Medical Technology, Chemistry or other Life Sciences; Medical Technology (ASCP or AMT certification) or PhD strongly preferred
- Strong technical lab expertise with demonstrated ability in assay analysis and data interpretation
- Experience in Cardiac clinical studies
- Knowledge of applicable standards and regulations for clinical trial and laboratory conduct
- Ability to work independently to analyze and solve problems, and to make sound decisions
- Basic biostatistical knowledge
CANDIDATE DETAILS
2+ to 5 years experience
PLEASE SEND RESUME TO:
summer @ pn-rn. com
1-855-582-5500
www .pn-rn.com
