Click Diagnostics is an early stage biotech startup that is looking to hire a Associate Systems Engineer to its engineering team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Director of Quality and Regulatory.
Scope of Position
The Clinical Affairs Sr. Manager/Director is an enthusiastic, self-motivated individual with great communication skills who can support the development and management of the Clinical Affairs program compliant with FDA regulations and ICH guidelines. The Clinical Affairs Sr. Manager/Director is responsible for the design, management and oversight of clinical trials in support of the development of new diagnostic tests.
- Design and oversee clinical studies from the planning to execution
- Collaborate with stakeholders from R&D, QA/RA, and Product to develop clinical strategies
- Manage resources and timelines associated with all clinical study activities including clinical trial agreements, IRB review, and testing agreements
- Ensure the appropriate development of all documents including but not limited to: study protocols and reports, informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
- Ensure maintenance of clinical files according to applicable regulations, guidelines, and corporate policy
- Direct and oversee CRO and other study related vendors in the execution of clinical studies
- Develop working relationships with external experts/opinion leaders
- Up to 25% travel required
Skills, Experience, Education
- BS in science or engineering required; MS or PhD preferred
- Minimum 10 years of Clinical Affairs experience required, preferably in IVD
- In-depth knowledge of GDA requirements for clinical validation and CLIA waiver
- In-depth knowledge of FDA, ICH, and GCP requirements
- Experience in managing women’s health trials preferred
- Salary, bonus, full benefits, company stock options
Please e-mail your resume to email@example.com with the subject "Clinical Affairs Sr. Manager/Director”.