Responsible to execute and/or support the following activities to ensure study delivery:
-Clinical project management of a clinical study
- Create and drive study level timeline
-Develop overall feasibility concept and enrollment plan with input from COMs
-Develop and manage study budget
-Provide input on operational aspects of the protocol- Ensure regulatory compliance and GCP compliance
-Responsible for oversight of TMF with periodic audits
-Responsible for/contribute to vendor selection and management including issue escalation
-Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
-Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
-Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings
-Ensure monitoring plan is developed and consistently executed in collaboration with COMs
-Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs- Assigns and documents study specific roles and responsibilities to internal and external team members
-Consult with COMs for strategic selection of countries and sites
-Facilitate and coordinate communications with external provider
-Ensure Clinical Operations team and external partner receive study specific training
-Report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
-Facilitate study close out activities through completion of Clinical Study Report
At minimum, bachelordegree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Otherdegrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degreeRN, certified medical technologist).
-A minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
-A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
-Experience in overseeing global clinical trials (pharmaceutical or research institute).
-Budget forecasting and management.
-Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
-Ability to work independently with some oversight in the support and/or management of clinical trial execution.