Clinical Monitoring Lead

3 weeks ago


Cambridge, United States TalentBurst, Inc. Full time
Experienced clinical scientist (PharmD, PhD, Nurse, etc..) in clinical development needed to support rare disease clinical trials from protocol development, study start up activities including investigator meetings, working closely with CRO and internal study team to meet study milestones, regulatory form creation and submission, ongoing data review, interaction with study sites, study team participation, driving towards top line data and database lock and CSR development. Activities include but are not limited to the following:

Collaborates with Global Asset Lead, Clinical development Lead, Clinical Operations, Global Patient Safety, Biometry & Data Management and any other relevant function to ensure that all development and asset support activities are coordinated and consistent
Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables
Development and review of clinical study documents ie ICF, protocol updates, CSR
Address routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
Monitor subject data and communicate with site study teams to obtain updates on subject status.
Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
Help lead clinical study team meetings and work closely with clinical operations for all aspects of trial conduct
Lead on preparations for Data Monitoring Committee meetings including quarterly safety updates and appropriate slide presentations.
Ensure concise written reports are provided as needed. Helps in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Assist in the review, analysis and reporting of clinical trial data and related publications
#TB_HC

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