We are seeking a highly experienced Lead Consultant in Life Sciences with deep expertise in the end-to-end clinical trial lifecycle. The ideal candidate will have hands‑on knowledge of clinical research processes, regulatory frameworks, and clinical trial data domains and standards.
Key Responsibilities
- Ensure clinical trial requirements align with regulatory, compliance, and industry standards.
- Lead functional requirements gathering and translate business needs into clear, actionable documentation.
- Create, maintain, and manage requirement artifacts for clinical studies.
Must-Have Skills & Expertise
- Strong expertise in the Life Sciences domain.
- In-depth understanding of clinical trial lifecycle, including study design, protocol development, site selection, patient recruitment, monitoring, and study close‑out.
- Knowledge of clinical trial data elements, Pharmacokinetics (PK), Pharmacodynamics (PD), modeling and simulation, and statistical analysis.
- Familiarity with clinical research processes and regulatory frameworks.
- Exposure to clinical trial data standards and domains.
Nice-to-Have Skills
- Experience with metadata structures, Case Report Forms (CRFs) design, and data capture flows.
- Understanding of clinical endpoints, biomarkers, and advanced statistical analysis concepts.
Experience & Certifications
- Minimum 10+ years of relevant experience in Life Sciences and clinical trials.
- Certifications: Not required