- Company Name
- Rangam
- Job Title
- RCI-ABBV-31345 Clinical Scientist (Oncology Clinical Trial/solid Tumors/EDC/CTMS/Myeloma) (Pharma/Biotech)
- Job Description
-
**Job Title:** Clinical Scientist II – Oncology (Solid Tumors / Multiple Myeloma)
**Role Summary:**
Provide scientific and clinical expertise for oncology drug development, focusing on solid‑tumor and multiple myeloma programs. Lead data review, contribute to regulatory and strategic documents, and support cross‑functional teams throughout clinical trial execution.
**Expectations:**
- Deliver high‑quality scientific input on study design, data analysis, and regulatory submissions.
- Maintain compliance with GCP, pharmacovigilance, and SOPs.
- Communicate findings effectively to internal and external stakeholders, including opinion leaders.
- Drive collaboration across clinical, regulatory, commercial, and medical education functions.
- Stay current with oncology literature and competitive landscape.
**Key Responsibilities:**
1. Review, interpret, and communicate efficacy and safety data from pre‑clinical and clinical studies.
2. Contribute scientific content to protocols, investigator brochures, CSR, informed consent forms, briefing documents, and regulatory filings.
3. Develop and maintain electronic data capture (EDC), clinical trial management system (CTMS), and IRT databases; ensure data completeness and integrity.
4. Support program strategy development (clinical development plan, target product profile, lifecycle planning).
5. Engage with key opinion leaders to foster collaborations and pipeline awareness.
6. Participate in scientific education for internal teams and external partners.
7. Author or co‑author regulatory responses and scientific publications as needed.
**Required Skills:**
- Oncology clinical trial experience, preferably solid‑tumor and multiple myeloma.
- Hands‑on data review, cleaning, and analysis using EDC, CTMS, and related databases.
- Ability to draft and edit scientific sections of protocols, IBs, CSRs, consent forms, and regulatory documents.
- Excellent written and verbal communication; strong organizational and teamwork abilities.
- In‑depth knowledge of multiple myeloma disease biology and treatment landscape.
**Required Education & Certifications:**
- Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD, PharmD) preferred.
- Experience with clinical trial methodology, regulatory compliance, and GCP standards.
- Relevant industry certifications (e.g., Certified Clinical Research Professional) are a plus.
North chicago, United states
On site
01-10-2025