Senior Clinical Study Manager
Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Develops and maintains liaison with clinical investigators, medical educators, clinical research organizations (CRO), affiliated hospitals, state and/or government hospitals, and research institutions to initiate and expedite clinical studies. Determines and monitors time schedules, prepares study documents, and issues status reports. May assist with design, development, and monitoring of clinical evaluation projects. (These roles do not require a specialized medical degree.)
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
Education/Experience:
At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).
Requirements:
-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.
Worker Type:
Employee
Worker Sub Type:
Regular
