2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Key Accountabilities(may include but not limited to the following):Clinical Trial Site ActivationInitiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.Provide support to resolve issues or concerns and ensure timely escalation of site issues where applicable.Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines.Manage and coordinate with supporting roles to ensure timely site activation and operational activities.Support the compilation of the Central Investigator Review Board package and submissions for study approval, complying with country requirements.Coordinate communication, documentation, and responses between the client and central ethics committees to facilitate study approval (country dependent).Support investigators with local IRB workflows from preparation to approval.Assist with preparation, handling, and distribution of clinical documentation and reports according to scope of work and SOPs.Support activities in Shared Investigator Platform (SIP) aligning with Pfizer strategy.Clinical Trials ConductPost site activation, coordinate activities and document management throughout the study lifecycle, including amendments and approvals.Ensure maintenance of IRB/Ethics activities as applicable.File documents timely to Trial Master File (TMF) and assist in quality reviews.Update and maintain clinical trial systems tracking site compliance and performance.Support investigator sites and study teams during audits.CommunicationMaintain ongoing contact with the study team, responding promptly to requests.Provide updates on country and site levels as needed.Establish tools for efficient updates regarding site status, issues, and delays.Disseminate ethics approvals to study team and sites.Clinical Trial Site SupportConduct awareness sessions with site personnel on requirements and compliance.Identify and resolve site issues within required timeframes, coordinating with study team and local colleagues.Subject Matter Expert (SME)Understand site activation requirements within the country/region and potentially implement in multiple countries.Serve as Site Activation Partner Point of Contact (PoC) for multi-country studies.Represent the SAP function as an SME on systems and processes.Participate in global initiatives as SME.Mentor new hires on processes and systems.Compliance With Parexel StandardsComplete required training and timesheets accurately.Submit expense reports and update CVs as required.Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and other requirements.SkillsKnowledge of clinical research, operational elements, and process details.Emphasis on quality and right-first-time approach.Compliance with regulatory and company standards.Attention to detail and disciplined approach.Ability to work independently and as part of a team.Organizational and multitasking skills.Understanding of medical terminology, GCP, and proficiency in computer systems.Ability to learn and use various systems independently.Proficiency in Microsoft Suite, CTMS, eTMF, eISF, SIP, ethics portals, and platforms.Flexibility to work off-hours in a global environment and willingness to travel, including international travel.Knowledge and Experience (preferred)Minimum 2 years' experience in clinical site management.Experience in pharmaceutical or CRO study site activation preferred.Knowledge of trial methodologies, ICH/GCP, FDA, and local regulations.Fluency in local language and English; multilingual capability preferred.Effective communication skills.Technical skills to learn and operate multiple systems.EducationSchool diploma or equivalent, or Bachelor’s degree in life sciences or related field.Seniority levelEntry levelEmployment typeFull-timeJob functionInformation TechnologyIndustriesPharmaceutical Manufacturing
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