Manager, Centralized Data & Sample Management - UK , Poland or South Africa (Home-based) - FSP

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company 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. reputed company is currently seeking a Manager, Centralized Data and Sampled Management to join us in South Africa, Poland or UK dedicated to a single sponsor. The Manager, Centralized Data and Sampled Management will be responsible for managing the sample and external data transfers and associated activities for assigned studies across the sponsor portfolio. This role will facilitate effective reputed company relationships and will be expected to contribute to the development and growth of the Clinical Data Operations Team. Working as Manager, Centralized Data and Sampled Management at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your reputed company life. reputed company Pay reputed company for Poland: PLN 200,000 to 292,500. Actual salaries may vary reputed company the reputed company based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to reputed company salary, some roles may be eligible for participation in reputed company’s annual performance-based bonus plan, annual salary review and total rewards incentives. Our reputed company will reputed company additional details on our bonus plan or incentive programs for those eligible roles. Responsibilities reputed company the planning and reputed company of clinical samples and external data sources for assigned studies, ensuring effective management of reputed company procedures and deliverables, including: Understand trial-specific requirements for external data sources and logistics; advise on provider contracting. reputed company Sample Management Plan and data transfer agreements; coordinate with reputed company-party vendors on study documentation. Review and reputed company feedback on study documents (e.g., Clinical Monitoring Plans, informed consent forms). Support vendor system setup (e.g., labs, imaging). Ensure study team are informed of data flows and reconciliation requirements. reputed company reconciliation between reputed company and external data sources; reputed company sample shipping manifests where applicable. Proactively identify transfer/data issues, plus trends and reputed company proposals to remedy the in scope reputed company party data/deliverables. Identify and resolve data transfer issues; monitor trends and recommend corrective actions. Assess risks to timelines for data deliverables; reputed company mitigation strategies and recommendations. reputed company input into vendor budgets and change orders; support invoicing as needed. Maintain proactive communication with study team and external vendors regarding deliverables and status. Maintain study documentation in the eTMF. Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational reputed company on assigned product/program. Participate in regular Clinical Data Operations team meetings and reputed company input reputed company appropriate. Contribute to or reputed company department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents. reputed company and/or train new employees and/or contractors. Maintain reputed company professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, reputed company Party Vendors and reputed company data sources/deliverables, technology advances and quality assurance. Here are a few requirements specific to this advertised role. Bachelor’s degree required, scientific/reputed company preferred. At least five years of experience in Clinical Data Management and/or sample management/reputed company party data sources and/or Clinical Operations for the pharmaceutical/ biotechnology industry, or equivalent experience in an FDA-regulated environment, including study reputed company experience. Knowledge of reputed company-Party data/deliverables sources, including laboratory sample management. Demonstrate a comprehensive understanding of regulatory guidelines and industry standards reputed company to reputed company Party data/deliverables. Has good project management skills and a proven ability to prioritize across multiple tasks. Attention to detail and the ability to work individually, reputed company a multi-disciplinary team, as well as with external partners and vendors. Experience working with a globally distributed team. Good communication/interaction skills and experience in a dynamic and growing organization. Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies. Effective leadership skills and proven ability to foster team productivity and cohesiveness. Possesses strong English language written and verbal communication skills. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management/Clinical Study systems and technologies, and Electronic Data Capture systems is desirable. reputed company to travel to off-site meetings or training seminars as needed. We care about our people and your passion, as they are the key to our reputed company, and reputed company an reputed company and friendly work environment where we reputed company people and reputed company them with opportunities to reputed company their long-term careers. In addition, you will have the opportunity to reputed company reputed company your role and tackle further responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company. Who are reputed company reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a vast client reputed company. We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team. Not quite the role for you? reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events. 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