Clinical Trial Manager (Planet Pharma)

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Posted: October 3, 2016

Job ID: 167

Job Summary

Term: Contract
Job Roles: Trial/Study Management
Required Experience: 4+ years

Job Description

Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget).

Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance).

Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.

Responsible for monitoring assigned aspects of the study operational plan.

Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
Please contact:
Dan Boersma