- Assist Medical Operations Manager (MOM) in planning and execution of a clinical study.
- Coordinate study activities (site selection, initiation, monitoring, closure, investigator meeting, site contract preparation etc) with or without vendors
- Assist Medical Operations Manager in coordinating Evidence Generation activities such as study design, protocol preparation, informed consent preparation, CRF design etc vendor selection and other activities to ensure on time completion of studies.
- Prepare Regulatory Authority (RA) and Ethics Committee (EC) submissions and follow-up approval letters in coordination with CTA
- Overview all activities of site personnel and motivate/influence them to meet study objectives.
- Perform site/vendor payments (including investigator payments) in coordination with CTA and work with MOM to ensure tracking of study expenditures in accordance with the planned study budget.
- Manage critical study documents including ISF/TMF/eTMF with CTA.
- Ensure safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable local regulations.
- Provide monitoring, site management all other related activities as defined in relevant sections of ICH-GCP Guidelines, in compliance with Abbvie GPRD SOPs and IQS process and procedures, local SOPs, applicable regulatory requirements and the monitoring plan.
- Report monitoring/contact visit activities in a timely, concise and objective manner.
- University degree in Life Sciences (Pharmacy, Biology, Chemistry, Genetics, Medicine or a related field)
- Preferably 2-3 years of clinical studies experience, especially in real-world data in pharmaceutical industry or Contracted Research Organization
- Strong project management and effective time management skills together with teamwork and excellence in communication with both internal and external stakeholders
- Excellent command of English and Turkish
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Ability to travel
Travel: Yes, 5 % of the Time
Job Type: Experienced