Required Skills and Experience
Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred.
Possess advanced knowledge of Clinical investigation of investigational drugs for human subjects.
Knowledge of Good Clinical Practice ICH/Google Cloud Platform and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements.
Clinical research/clinical trial management certification/education preferred.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Excellent communication skills.
Experience with protocol and ICF development, and related amendments.
Experience negotiating clinical research contracts and budgets.
Must be able to work effectively cross-functionally.
Must be able to travel up to 40%.
Must be able to manage multiple priorities.
Excellent communication, presentation and relational skills with high attention to detail and organization
Ability to learn quickly, adjust to shifting requirements, and self-educate on different as applicable to clinical projects ( Self-starter attitude ).
Exhibits solid work ethic to help meet tight timelines and/or multiple priorities when necessary with a problem-solving mindset.
Proficiency in Microsoft Office Suite, PDF applications.
Experience working with electronic data capture (EDC) systems required.
Experience in clinical trial management systems.
Previous experience implementing, helping and managing drug trials.
Significant knowledge of clinical and/or outcomes research study.
Possess advanced knowledge of Clinical investigation of Investigational drugs for human subjects - Good Clinical Practice and other applicable regulations.
Knowledge of clinical research and monitoring requirements.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Qualifications
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