Summary of Position:
This position has responsibility for directing and performing clinical data review activities for Aravive clinical trials. The Clinical Scientist will work internally across functions and externally with study vendors and clinical sites to ensure Aravive clinical trial data are complete, accurate, comprehensive, and consistent, in accordance with the protocols and eCRF Completion Guidelines. The successful candidate will lead day to day clinical data review tasks within Aravive, provide guidance to study personnel to ensure data are cleaned appropriately, and streamline data review processes across Aravive clinical trials.
Job Title: Clinical Scientist
Reports to: VP, Clinical Operations
Employment Type: Full-Time
FLSA Status: Exempt
Required Skills & Abilities:
- Lead the Integrated Data Review Team, including internal and CRO personnel, to ensure data are cleaned on a timely basis
- Perform high quality clinical data review and identify clinical data insights through ongoing review of patient profiles and data tables/listings
- Support study interim and final analyses as well as interim data cuts through ad hoc data review, including oversight of additional contract data reviewers as needed
- Work collaboratively with the Clinical Operations Lead, Data Management Lead, and Medical Monitor for each study, to ensure an accurate group understanding of clinical data expectations
- Provide data trends and analysis to study personnel, including training of CRAs and site staff as needed
- Lead data review planning and strategy, including input on data tools such as the CRF and TLFs
- Serve as a resource for study teams regarding scientific, clinical, and oncology questions, supporting Medical Monitoring
- Issue, review, and resolve queries in EDC as required
- Detail oriented and accurate, excellent communication skills both written and spoken.
- Communicate status and escalate ongoing issues to ensure timely decision-making
- BA/BS in scientific field of study. Advanced degree (Master’s, PharmD, PhD) preferred.
- 10+ years of clinical experience in a CRO or pharmaceutical company
- 5+ years of experience in clinical science or clinical research, with a minimum of 3+ years experience in data review
- 5+ years of oncology experience, including in-depth knowledge of NCI CTCAE and RECIST
- Expertise in clinical data collection and reporting; demonstrated ability to use data systems and tools (e.g., EDC, Excel, j-Review or equivalent)
- Proficient knowledge of GCP/ICH, Phase I-III drug development, and medical terminology
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is focused on treatments for cancer. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC. For more information, please visit our website at http://www.aravive.com.
Please send resumes and cover letters to firstname.lastname@example.org