Clinical Site Manager

Description

• Direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include:
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
• Develop a strategy to configure, distribute, and collect, and review and approve, high quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies for:
• IRB/IEC and MoH / RA submission/approval,
• Site activation,
• Patient recruitment & retention.
• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with a limited need for oversight.

• Direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include:
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
• Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies for:
• IRB/IEC and MoH / RA submission/approval,
• Site activation,
• Patient recruitment & retention.
• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with a limited need for oversight

• Able to take initiative and work independently, and to proactively seek guidance when necessary.
• Excellent presentation skills.
• Client-focused approach to work.
• Ability to interact professionally within a client organization.
• A flexible attitude with respect to work assignments and new learning.
• Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
• Strong ability to make appropriate decisions in ambiguous situations.
• Willingness to work in a matrix 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.
• Excellent interpersonal, verbal, and written communication skills.
• Sense of urgency in completing assigned tasks and the ability to assist others to meet study/ country deliverables.
• Excellent time management in order to meet study needs, team objectives, and department goals.
• Proven ability to work across cultures.
• Shows commitment to and performs consistently high-quality work.
• Ability to successfully work in a ('virtual') team environment.
• Consulting Skills.
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
• Act as a mentor and role model for other team members.
• Effectively enlist the support of team members in meeting goals.
• Attention to detail.
• Holds a driver's license where required.