Senior Consultant, SME - Pune, India - Saama

Description

Description
Mandatory Skills - A SME has at least 5-7 years of relevant deep practical experience in Clinical Trials and related areas.
1) Strong understanding of clinical trial data, along with experience in company/ product /disease profiling.
2) Experience using various healthcare databases and Data Models.
3) Analyze and interpret structured and unstructured data, draw conclusions and develop recommendations along with the data engineering team.

4) Serving as a Technical Lead-SME for Clinical Analytics platform, having good knowledge of different domains such as Clinical Trials, RWD, Laboratory, PG (Proteomic & Genomics) data.

5) Research, document and plan out all aspects of international healthcare conferences on behalf of the client.
6) Advises on statistical analysis plans execution & Perform RWD analytics QC.
7) Oversees CROs and vendors to ensure timelines, goals and deliverables are met with quality, within budget, and in accordance with SOPs, GCP and all applicable laws and regulations.
8) Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Director of Clinical Operations as necessary.

Good to have: Showcased expertise in CDISC terminologies along with new data source such as Translational Data, FC data (Flow Cytometry), OMICS Data and Coding Data includes MedDRA SOC, ICD-9/10, NDC, HCPCS, CPT etc. With the help of current AI-ML based technologies, provided solutions to the client for their Epidemiological research.