Global Site Activation Analyst
The Global Site Activation Analyst role would provide an opportunity for selected candidates to enhance their knowledge(Site-Id to Close-out activities) & skills(Analytics, Project Management etc.). This role would partner with SAM & work closely with Maintenance Leads, Site-Id leads, Study Team members etc. on various tasks.
• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
• Bachelor´s degree in Life Science or related field.
• At least four year of clinical research experience.
• In-depth knowledge of Clinical trial environment and Drug development process.
• Good Analytical skills & understanding of reports (Spotfire, CTMS)
• Good knowledge of various Tools & Systems used during start-up (eg. CTMS, eTMF, Wingspan, Workflow tools (RSU WF/ DrugDev etc.), RID, Advanced Excel, Word, PPT etc.)
• Good knowledge of multiple Startup activities(Global & Regional) would be an advantage.
• Good Communication & Collaboration skills.
• English Level advanced.
• Good Planning & Problem solving skills.
• Ability to manage complex tasks independently.
• Understanding of SAM roles & responsibilities would be an added advantage.
DUE DATE TO RECEIPT APPLICATIONS AUGUST 31st 2021
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