Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Associate. Lead pivotal clinical trials from protocol design to final report, ensuring GCP compliance and data integrity. Collaborate with cross-functional teams to accelerate life-changing therapies to market. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a dynamic pharmaceutical environment.
Responsibilities
- Design, monitor, and manage Phase I-III clinical trials across multiple therapeutic areas
- Ensure protocol compliance and regulatory adherence (ICH-GCP, FDA, EMA)
- Lead site selection, initiation, and closeout activities with global CROs
- Analyze clinical data and prepare regulatory submissions (IND/CTA/BLA)
- Mentor junior CRAs and optimize clinical trial processes
- Represent the company at investigator meetings and audits
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years of clinical research experience with 2+ in CRA roles
- ICH-GCP certification and current knowledge of FDA/EMA regulations
- Proven track record in managing complex multi-site trials
- Strong data management and risk-based monitoring skills
- Excellent written/verbal communication and leadership abilities
- Experience with EDC systems (e.g., Medidata Rave, Veeva Vault)