Develops work processes or fosters an environment that enhances the cross-functional effectiveness of clinical operations with other functions such as biostatistics, data management, CMC, medical writing, regulatory, finance, and legal, whether these functions are internal or external to the company.
March 23, 2023
Provides high level oversight of clinical study data, i.
April 14, 2023
Demonstrates strong problem-solving and leadership skill-sets.
April 26, 2023
Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals.
May 13, 2023
Lead the operations team in the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution and ensure proactive management of CRO performance across the operations team and functions.
January 02, 2023
Contribute to authoring clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities' questions.
February 01, 2023
Build, support and leverage multi-functional operations team to deliver on company, department and program, and study goals.
March 31, 2023
Collaborate with CMC/clinical suppliers to provide drug supply assumptions and contribute to design and packaging of supplies for clinical programs and trials.
April 01, 2023
Manage the clinical operations group to support overall set-up, execution and delivery of multiple global clinical programs, including project planning, budget and resource management, CRO and vendor management.
April 23, 2023
Evaluate and implement optimal outsourcing models to deliver on the portfolio.
May 02, 2023
