The Regional Clinical Scientist will work with the Study Medical Monitor/Study Clinical Scientist and provide scientific and clinical support from ongoing early and late stage clinical trials with an emphasis on protocol-specific, in-life clinical data monitoring activities.
This role will also serve as a point of contact for CROs, Investigators and study staff in day-to-day safety monitoring under the guidance of the Study Medical Monitor.
This individual will report into Global Clinical Operations, and will interface directly with the Study Clinical Scientist and other cross-functional team members (including Clinical Development, Global Clinical Operations, Data Management, Biometrics, Patient Safety, Clinical Pharmacology and Biomarkers) to support clinical study execution and clinical data monitoring.
This is a remote role based in regions relevant to clinical trials.
Responsibilities include: Support Study Clinical Scientist in medical surveillance and medical monitoring activities under the guidance of the Medical Monitor; conduct daily medical surveillance of laboratory & ECG alerts including review of eligibility criteria as appropriate.
Provide analytical support of clinical trial data, including assessment and follow-up of issues relating to protocol conduct and/or individual subject safety.
Gather, review, and provide preliminary assessments of medical surveillance events to the Study Clinical Scientist and the Study Medical Monitor.
Generate study safety events trackers, periodic medical monitoring reports and safety reviews in line with the needs of the study.
Participate in cross-functional study execution team activities relating to clinical data review.
Contribute to ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Monitor/Study Clinical Scientist as applicable.
Interact with internal and external stakeholders (study sites, vendors, etc.)
in support of clinical trial objectives related to subject safety and clinical data monitoring; respond to or triage medical and safety-related questions for appropriate actions.
Perform other duties as assigned related to clinical programs.
Minimum Requirements: Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution.
Experience working with clinical trial sites.
Experience in all stages of drug development.
Ability to make independent, timely and appropriate decisions.
Ability to handle multiple projects at a time and have a strong attention to detail.
Excellent oral and written communication skills and solid computer/analytical skills.
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
High level of organizational and project management skills.
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