Site Activation Management Associate

Lilly İlaç

• Bachelor’s degree is a must, Science and/or Pharmacy faculties background is preffered,
• At least 1 year experience in Clinical Research and Regulatory Submission Process,
• Upper-intermediate level of English,
• Excellent computer skills with experience in Microsoft office programs,
• Ability for multitasking and prioritization,
• Stress management skills,
• Excellent teamwork/interpersonal skills,
• Ability to work according to strict deadlines, prioritize and manage multiple customers,
• Strong follow-up skills,
   

.

İŞ TANIMI

• Ensure country level regulatory requirements within internal databases (eg. Requirements for the initiation of Trials in Affiliates
• Communicate site-level site activation updates to sites and appropriate study team members as appropriate
• Collaborate with the Clinical Research Administrator (CRA), Clinical Development Liaison (CDL), Country Study Manager (CSM)  to declare site regulatory and site readiness for enrollment
• Collaborate with the Clinical Research Administrator (CRA), Clinical Development Liaison (CDL), Country Study Manager (CSM) to manage site activity/performance during the site activation and maintenance phases of the trial
• Prepare submission files
• Responsible for coordinating Access Control of Study Systems
• Develop/Maintain country-specific clinical research contracts between Lilly and external parties in cooperation with legal and compliance functions
• Coordinate the training related to contract/budget topics to the involved personnel
• Provide support before and during audits/inspections
• Cooperate with CDL and MQR to ensure appropriate audit/inspection responses are provided and implement corrective actions