Overview In this role you will support planning, execution, and reporting of Phase I-III clinical studies within the pharmaceutical domain. You will collaborate with clinical staff and external CROs to monitor trial conduct and ensure GMP/GCP compliance. You will analyze data, assist in study documentation, and help manage risks across multiple protocols under limited supervision. This position offers hands-on experience shaping clinical programs and contributes to timely, compliant trial outcomes.
Responsibilities- Assist planning, implementation, and reporting of Phase I-III clinical studies
- Prepare and review protocols, study reports, SAE narratives, and regulatory dossier sections
- Perform literature searches and data analysis to address research questions
- Monitor clinical trial conduct with CROs; ensure GCP and safety handling
- Support database cleaning, review results, and interpretation
- Adhere to KPIs for study development, conduct, and reporting
- Handle multiple protocols simultaneously and escalate project risks
- Contribute to planning, execution, and reporting of clinical programs/trials
Key requirements- 5-7 years of experience in clinical research in the pharmaceutical industry
- Understanding of clinical research methodology including study design, protocol writing, and CRF preparation
- Knowledge of GCP and local regulatory requirements
- Working knowledge of IND/NDA/CTD/MAA process (preferred)
- Knowledge of oncology clinical research techniques
- Bachelor's degree required; Doctoral (PharmD or PhD) degree preferred
- Excellent communication of concepts and data
- problem-solving and troubleshooting
- ability to work with limited supervision
- GCP knowledge
- clinical study design and protocol writing
- CRF preparation
