The Global Clinical Operations Lead (GCOL) is responsible for the on-time delivery of a clinical study (studies).
The GCOL is responsible for clinical operational planning activities and leading study execution. The GCOL works closely with the Senior Global Clinical Operations Lead (Snr GCOL) on a program or leads one or more studies and may take on additional responsibilities as dictated by study size and complexity. The GCOL participates in or may lead the study execution team (SET), oversees study level outsourcing, and takes preventive/corrective action(s) to address study level issues.
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment
- Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
- Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/GCP, Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills.
- Maintains computer literacy in appropriate software.
At minimum, bachelor’s 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).
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Our areas of expertise include Information Technology, Engineering, Accounting/Finance, Scientific/Clinical, Professional, Mortgage, Administrative/Clerical, Call Center, Human Resources, and Marketing/Creative. ICONMA has a nationwide presence that helps us support our national clients. For more information, please visit us at www.iconma.com.
IconmaICONMA is a certified Woman-Owned nationwide consulting firm providing Professional Staffing and Project Based Services and Solutions for Fortune 1000 clients in a broad range of industries. Our areas of expertise include Information Technology, Engineering, Accounting/Finance, Scientific/Clinical, Professional, Mortgage, Administrative/Clerical, Call Center, Human Resources, and Marketing/Creative. ICONMA has a nationwide presence that helps us support our national clients. For more information, please visit us at www.iconma.com.