What are the responsibilities and job description for the Lead Consultant position at Career Soft Solutions Inc?
Job Details:
Title: Lead Consultant
Location: Groton, CT
Must Have Skills
Strong expertise in Life Sciences domain with deep understanding of endtoend clinical trial lifecycle
The domain knowledge requirement is very niche which includes Clinical Trial data elements, Pharmacokinetics, Pharmacodynamics, modelling, and simulation etc
Indepth knowledge of clinical research processes and regulatory frameworks. Exposure to clinical trial data domains and standards
Nice to have skills
Solid understanding of Clinical trial data elements and metadata structures and Case Report Forms (CRFs) design, data capture flows.
Understanding of clinical endpoints, biomarkers, and statistical analysis concepts
Detailed Job Description
Strong expertise in Life Sciences domain with deep understanding of end to end clinical trial lifecycle Study design, protocol development, site selection, patient recruitment, execution, monitoring, and study close out. Indepth knowledge of clinical research processes and regulatory frameworks. Exposure to clinical trial data domains and standards. Solid understanding of Clinical trial data elements and metadata structures and Case Report Forms CRFs design, data capture flows. Understanding of
Minimum years of experience
>10 years
Top 3 responsibilities you would expect the Subcon to shoulder and execute
Ensure requirements align with clinical, regulatory, and compliance standards.
Lead functional requirements gathering and translate business needs into clear documentation.
Create and maintain requirement artifacts.