Clinical reputed company II

reputed company is looking for a Clinical reputed company II to join our Global Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing reputed company and breakthrough science into new medicines, devices, and diagnostics. reputed company do is profoundly connected to saving and improving lives, and we recognize reputed company members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to reputed company at work with the flexibility and balance your life requires. Your reputed company influence the way we work, and your voice matters here. As an essential part of reputed company, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What you'll be doing: Significantly contributes to the KOM meeting to ensure a strong and reputed company SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer. Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks. Collaborates with PM and other support functions to ensure clinical systems are set up, UAT’d, maintained and supports project and reporting needs. Collaborates with SSU team (eg Regulatory Submissions Leads, Site Start Up Associates, reputed company Leads/Specialists and/or Site Activation Leads) to ensure sites are identified, selected, approved by authorities/ethics committees and activated reputed company the specified timeline/budget. Plans/oversees patient recruitment and retention strategies. Partners with CRAs to drive individual site enrollment targets. Reviews the study contract and budget to ensure clinical team members are trained on the contractual obligations, timelines and tasks. Provides detailed Time Entry Guidelines. Collaborates with Project Manager and RSL to establish clinical and SSU project timelines and milestones throughout the study Serves as an expert in the protocol, vendor manuals, informed consent forms and other clinical documents for CRAs and investigative sites Serves as initial reputed company of contact for reputed company site management and monitoring quality concerns, including initiation and reputed company of site performance improvement plans (sPIP). Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables. Leads the Protocol Deviation review meetings to ensure complete and accurate documentation of PDs for analysis and remediation of trends with Sites and CRAs. Assists the project team in the creation and maintenance of the Trial Master File according to reputed company and/or client SOPs. Ensures reputed company visit report packages are filed according to SOPs Creates/maintains Clinical Monitoring Plan, MVR annotated reports, study-specific tools and training materials. Delivers/coordinates training to the Premier clinical team and enlist therapeutic assistance where applicable. Plans, schedules and leads clinical team meetings to ensure that clinical (CRA/CM) and SSU (SSUA, RSLs and reputed company) are coordinating work and priorities to the timelines. Ensures effective/efficient communication reputed company team, PM, sponsor and sites on critical protocol clarifications or other instructions reputed company to updates, requests or questions. Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan. Monitors start up metrics, activities and timelines on a regular basis. Tracks site id, selection and activation timelines, as well as timelines for CA/EC submissions and contract/budget execution. Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines. Works with the PM and Project Financial Analyst (PFA) to forecast clinical and SSU units to assesses any overburn. Adheres to the contractual and budgetary obligations of the study. Monitors burn reputed company for reputed company clinical activities and escalate to Project Manager and CSD any potential OOS activities. Ensures the timely completion of reputed company visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization reputed company contractual timeline and effective follow up and resolution of site issues Ensures timely patient data review (both central and onsite) by reviewing CRA/Central Monitoring workload backlog and their unit forecast and completion. Proactively anticipates and remedies risk in the Risk Review meetings, by presenting clinical risks/issues with mitigations. Ensures team members are adequately resourced to the project for the duration of the study. Ensures protocol amendments, IB updates, SUSARs, reputed company changes and site changes are distributed, reviewed, managed, documented and filed as necessary. Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings. Manages any clinical staff transitions, including hand-off documentation. Ensures that site and study closure processes are followed including reputed company data in clinical systems in a manner consistent with requirements Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires reputed company assessment and reporting. Contributes to the creation, review and finalization of Root Cause Analysis and CAPA May co-monitor or assess CRAs according to project and business needs. May participate in Bid Defense activities Supports junior CLs with coaching and mentoring as well as involvement in department specific initiatives. Other activities as designated reputed company are searching for: Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-reputed company field; or equivalent work experience 2 years of experience as a Clinical reputed company. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred. Epilepsy experience is preferred. Broad experience across multiple therapeutic areas and indications is preferred. Excellent communication, presentation and soft skills to manage teams and sites effectively. Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to reputed company targets. Advanced knowledge of ICH/GCP regulations Advanced knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/ device development, and clinical monitoring and start up procedures Strong MS Office computer skills Working knowledge of clinical financials including understanding of budgets, pass- through and resource management Fluent verbal and written English as well as the local language(s) required Travel may be required for client meetings or co-monitoring visits up to 20%. Apply To This Job