Anadil Shaikh
Senior Clinical Scientist/Associate Director
- Role
- Senior Clinical Scientist Associate Director at Bristol Myers Squibb
- Location
- Lodi, NJ, US
- LinkedIn followers
- 500 followers
Experience
Senior Clinical Scientist Associate Director
Nov 2022 — Present · Madison, NJ, US
Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members. Plan and lead the implementation of all study startup/conduct/close-out activities as applicable. Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead) Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality (collaboration with Medical Writing) Site-facing activities such as training and serving as primary contact for clinical questions. Activities related to data generation and validation, including CRF design, and clinical data review/query resolution; ensure consistent, quality data review by supporting the CS team. Clinical data trend identification: provide trends and escalate questions to the Medical Monitor Develop a clinical narrative plan; review clinical narratives. Provision of information required by the Protocol Manager for the development of the trial budget, CRO scope of work, etc. Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g, DMC) activities Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g, IB, DSUR, regulatory responses) Collaborate and serve as the primary liaison between external partners for scientific advice.
Education
South Gujarat University, Surat, Gujarat, India
Master’s Degree, Statistics
St. Joseph's E.T. High School, Valsad, Gujarat, India
Higher Secondary Certificate, Physics, Chemistry, Biology and Mathematics
V.S. Patel College of Arts and Science, Bilimora, Gujarat, India
Bachelor’s Degree, Mathematics and Statistics
Skills
- CRO
- Infectious Diseases
- Oncology
- Clinical Monitoring
- Ich-Gcp
- Clinical Development
- Biotechnology
- Clinical Trials
- Cdisc
- Clinical Research
- Sas
- Pharmaceutical Industry
- Sop
- Clinical Data Management
- Oracle Clinical
- Regulatory Submissions
- Biostatistics
- Edc
- Therapeutic Areas
- Ctms
- Data Management
- Drug Development
- Gcp
- Clinical Study Design
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