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- Clinical Site Manager / CRA
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Clinical Site Manager / CRA
Parexel International Corporation
Seoul, Seoul, South Korea
Consistently meet the requirements of a ICSM I with a high degree of proficiency, accuracy, and autonomy:
• Conduct country specific feasibility and/or site pre-qualification
• Review and validate site identification list
• Collect and negotiate Confidentially Agreements (CDA) as required
• Organize translations per country/regulatory/client requirements
• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)
• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments
• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)
• Prepare and negotiate as required initial and/or amended CSA at a site level
• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required
• Collect internal CSA signatures
• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)
• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)
• Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training
• Ensure good understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
• Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan
• Escalate any site and study issues that require immediate action to the Functional Lead (FL)
• Proactively work with team members to meet project goals
• Show commitment and perform consistent high quality work
In addition;
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Manage sites and protocols across multiple therapeutic areas independently
• Support less experienced staff on project assignments as appropriate
• Recognize out of scope activities and communicate to FL
• Recognize impact of issues/delays/changes on study timelines and communicate to FL
• Participate in internal audits/client meetings with support
• Require minimal supervision by ManagerQualificationsSkills
• Good presentationskills
• Client focused approach to work
• Ability to interact professionally with external customers.
• Flexible attitude with respect towork assignments and new learning
• Advanced ability to manage multiple and varied tasks with enthusiasm
• Attention to detail
• Willingness to work in a matrix and virtual team environment and to value the importance of teamwork
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS- Office products such as Excel and Word
• Strong interpersonal, verbal, and written communication skills
• Advanced problem solving skills
• Sense of urgency in completing assigned tasks
• Effective time management in order to meet daily metrics, team objectives, and department goals
• Ability to work across cultures
• Ability to work independently with little oversight and to proactively seek guidance when necessary
• Strong ability to influence and negotiate resolutions and outcomeswith sites
• Willing and able to travel locally and internationally occasionally as required
Education
• Educated to degree level (biological science, pharmacy or other health-related discipline preferred),nursing or other relevant qualification/experience
Language Skills
• Proficient in written and oral English and fluent in relevant local language
Minimum Work Experience
• Previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology
Job posted: 2020-05-25