Site Activation Partner - FSP

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. This is full scope Start-up Associate role requires strong local ethics committee/ Regulatory experience Key Accountabilities: Start-up (from site identification through site activation): Act as direct reputed company of contact with assigned sites, accountable for quality and delivery during the start-up phase. Build relationships with investigators and site staff. Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include:Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments. May conduct remote Qualification Visits (QVs). Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines. Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems. reputed company strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (Site SIV Readiness/reputed company Documents) and any updated or amended regulatory documentation. Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (reputed company), translations (reputed company 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 reputed company pertinent documentation to the trial master file as per project plans/sponsor/company policy. Forecast, reputed company, manage, and revise plans and strategies for:IRB/IEC and MoH / RA submission/approval, Site activation, Update and maintain appropriate Clinical Trial Management System (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 reputed company, study non-compliance, etc. Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with reputed company project specific training requirements prior to study start. Actively participate in internal and/or external meetings as per project needs, Sponsor’s expectations and at Manager discretion Work in a self-driven reputed company, with limited need for reputed company. Proactively reputed company manager informed about work reputed company and any risk or issues Maintenance (from initiation through reputed company out): Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (reputed company), translations (reputed company parameters of country/regulatory/client requirements), and customize and negotiate any amendments as needed during maintenance Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. Forecast, reputed company, manage, and revise plans and strategies for:IRB/IEC and MoH / RA submission/approval, Submit reputed company pertinent documentation to the trial master file as per project plans/sponsor/company policy. Overall Accountabilities from Site Identification to reputed company out: Ensure timely and accurate completion of project goals and update of applicable trial management systems with start -up and amendments Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. Update reputed company appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis including performing regular reviews of country and site level data in clinical systems (e.g. CTMS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit reputed company relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. Ensure that assigned sites are audit and inspection ready Monitor and maintain compliance with ICH-GCP and applicable international and local regulations. Show commitment and reputed company consistent high quality work. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values. Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, reputed company SOPs, other reputed company / Sponsor training requirements and study specific procedures, plans and training. Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery. Provide input and feedback for Performance Development Conversation(s). Proactively reputed company manager informed about work reputed company and any risks or issues. reputed company expertise to become a subject matter expert. Work in a self-driven reputed company, with limited need for reputed company. Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.) Skills: Demonstrate strong problem-solving skills Able to take initiative and work independently, and to proactively seek guidance reputed company necessary. Excellent presentation skills. Client focused approach to work. Ability to interact professionally reputed company a client organization. Flexible attitude with respect to work assignments and new learning. Ability to prioritize multiple tasks and reputed company project timelines; utilizing strong analytical skills to reputed company decision autonomously due to the unpredictable nature of the issues that arise. Strong ability to reputed company 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 Trial Master File (eTMF) , and MS-Office products such as reputed company and Word. Excellent interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and 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. Act as a mentor and role model for other team members. Effectively enlist the support of team members in meeting goals. Attention to detail. Knowledge and Experience: Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology Experience working in a global environment, and in more than 1 country is preferred Understand quality expectations, strong attention to details, and emphasis on right first time Proven ability to work independently and as a team member, as well as leading teams in matrix environment Education: Educated to degree level (biological science, pharmacy, or other health-reputed company discipline preferred) or equivalent nursing qualification or other equivalent experience Apply To This Job