Our client is seeking a Clinical Research Manager in Boston, MA!
Our client specializes in diagnostic IVD Point-of-Care instruments in blood management and hemostasis testing. The company holds an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future- perhaps even internationally!
Responsible for development, management and reporting of external evaluations conducted at the company’s clinical sites.
- Leads development of independent protocols and reports for external Beta trials at clinical sites, and internal sites if necessary.
- Leads the development of contracts, budgets and the necessary I RB's for each project, and develops a network of reliable sites for continuing relationships in Beta trials performance.
- Coordinates planning of resources for multiple concurrent external trials from all product lines to ensure appropriate personnel and equipment/materials for each trial.
- Leads monitoring of active trials including activities related to ensuring protocol compliance, troubleshooting and other remote and on-site support for personnel, interim data collection and coordination with the appropriate technical group, and communication with project team and management as required.
- Represents Clinical Affairs in cross functional teams and works with QA/RA on study design to meet FDA requirements.
- Manages the Clinical Affairs group including all training, evaluations and compliance with the company’s code of ethics and policies.
- Ensures that all members of the Clinical Affairs team obtain training and a level of certification in Good Clinical Practices.
- Ensures the team is complaint with all Quality Systems training requirements and obtains a degree of proficiency and cross training on all of the instrument platforms.
- Serves as a resource to other groups for Good Clinical Practices
- Advanced degree in Life/Health Sciences and/or a minimum of 10 or more years' experience in the clinical laboratory and/or IVD industry or equivalent.
- Project management experience is a plus.
- Experience with writing technical protocols and reports including execution of data manipulation and analysis with software for IVD method evaluation
- Knowledge and experience with medical device regulations, CLSI guidance documents, product development, design controls, IVD instrumentation, clinical chemistry and laboratory practice to make informed decisions on protocols and reports.
Qualified Candidates, Please Send us your CV
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