Job Reference: SJSH4573
Job Duration:
Start date:
Description:
A growing and well established CRO recognised as one of the best CROs to work for is looking fora Study Start Up Leader. The Study Start-up Leader leads all aspects of Clinical Start-up activities at the EU level to achievesuccessful activation of sites within timelines will manage all the study start up related activities including preparation, review and approval of local site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards
Day to day responsibilities include but not limited to:
*Management of site start-up activities on global clinical trials
*Providing adequate start-up estimations in terms of timelines, budget and resources and ensuring project stays within the given constraints.
*Provide leadership to Study Start up and Regulatory Affairs coordinators, including review of workload, allocation and utilization.
*Set up & implementation of new internal processes to improve communication and efficiency in the department
*Lead the process of negotiations with sites and sponsors for contracts preparation andbudgets.
*Review study performance in each country and instigate actions to improve performance.
*Ensure that study authorization activities are in alignment with department metrics and goals.
*Perform quality checks on submission documents and site essential documents;
Role Requirements
*Bachelor's Degree in science related field.
*In depth proven clinical research industry experience in order to manage all aspects of submissions (start-up and ongoing), and study start-up activities as applicable for EU countries.
*Thorough knowledge of regulatory and EC submission requirements in EU countries
*Thorough knowledge of ICH, GCP and other relevant regulations for the conduct of clinical trials
For detailed job description and for additional information please contact me on vamsi.gentela@secpharma.com
Industry: Pharmaceuticals
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: -
Contact Name: Vamsi Gentela
Website: -
Direct Application URL: -