Markus Maldener’s Post

Navigating the Pharma Landscape with Veeva: Seeking New Opportunities As a Business Analyst in the Pharma and healthcare domains, I've gained invaluable experience with Veeva, a leading cloud-based software solution. Veeva RIM and Veeva Vault streamline regulatory information management and document control, ensuring compliance and efficiency. These tools are critical for navigating the complex regulatory landscape, allowing seamless data management and collaboration across teams. Challenges like maintaining data integrity and regulatory compliance are met head-on with Agile methodologies and Jira, enabling adaptive project management. Crafting detailed Business Requirements Documents (BRDs) aligns stakeholder expectations and ensures project success. Every challenge enhances my skills and drives innovation. I’m passionate about optimizing processes and achieving impactful results. Currently, I’m seeking new opportunities to contribute to transformative projects in the industry. #BusinessAnalyst #Pharma #Healthcare #Veeva #VeevaRIM #VeevaVault #GXP #Agile #Jira #BRD #RegulatoryCompliance #DataManagement #ProjectManagement #Innovation #Growth #Challenges #NewOpportunities

In healthcare and medical data-driven projects, new people may be added to the coding team in different parts of the project, or coding team members may want to work together in different parts. Therefore, it is very important to control different versions. Version control allows developers to track and manage changes to the codebase, ensuring that updates and modifications can be applied systematically, while maintaining a history of previous versions. This helps in ensuring consistency and transparency in the contract's behavior, facilitating collaboration among developers, and making it easier to identify and resolve any issues or bugs that may arise during development or deployment. Version control provides a clear audit trail, which is essential for regulatory compliance and accountability in the healthcare sector, Such points are seen as of little value, but they are very important in a data-driven project. #healthcare #artificialintelligence #data #technology #project

Project technical support in clinical operations involves providing technical assistance and expertise to ensure the smooth functioning of clinical trials. This support can include: 1. Technology Implementation: Assisting with the implementation and utilization of technology systems and software used in clinical operations, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic patient reported outcomes (ePRO) tools. 2. Troubleshooting: Identifying and resolving technical issues that may arise during the course of the trial, such as system glitches, data entry errors, or connectivity problems. This may involve collaborating with IT teams or vendors to address and resolve these issues promptly. 3. Training and Support: Providing training and support to clinical trial staff on the proper use of technology systems and tools. This can include training sessions, documentation, and ongoing assistance to ensure that all users are proficient in utilizing the technology effectively. 4. Data Management: Assisting with data management processes, including data entry, data cleaning, and quality control checks. This may involve developing data management plans, ensuring adherence to data standards, and implementing data validation processes. 5. System Validation: Participating in system validation activities to ensure that technology systems used in clinical operations meet regulatory requirements and industry standards. This may involve conducting user acceptance testing and ensuring the system's compliance with data privacy and security regulations. 6. Continuous Improvement: Collaborating with cross-functional teams to identify areas for improvement in clinical operations and suggesting technological solutions to enhance efficiency, data quality, and participant safety. Overall, project technical support in clinical operations plays a crucial role in leveraging technology to streamline processes, improve data management, and enhance the overall effectiveness of clinical trials. #projectmanagement #clinicaltrialmanagement #clinicaltrial #research #clinicalresearch #trials #humantrials #career #opportunity #learning #sponsor #healthcare

[ES] #Oportunidad que le podría servir a alguien de mi #red. [EN] #Opportunity that could be useful to someone in my #network. #translationjobs #job #vacancy #assigntotranslators #traducción #translation #trabajo #traducción #assigntofreelancers #litranslators #translator #freelancetranslators #freelance #translator #linguist #PM #ProjectManager

🚀 Day 12- Mastering Clinical Data Management🚀 🔍Quality Control in Start-Up Phase🔍 🔍 What is Quality Control (QC) in Clinical Data Management?  QC refers to the process of ensuring data accuracy, consistency, and compliance in clinical trials. It's all about identifying and correcting errors early, ensuring the integrity of the data collected. ⚡ Why is QC Crucial in the Startup Phase? During the startup phase of a clinical trial, QC plays a pivotal role in setting the foundation for a successful study. Here’s why it’s essential: 1. Accurate Data Management Plans – QC ensures that the data management plan (DMP) is aligned with regulatory guidelines, documenting all processes for data capture and validation. 2. CRF & Database Design– QC checks that Case Report Forms (CRFs) and clinical databases are correctly designed, reducing the risk of data discrepancies and ensuring smooth data flow. 3. Edit Checks & Compliance – QC ensures that edit checks are in place to catch errors during data entry and ensures compliance with industry standards. 4. UAT & System Validation – User Acceptance Testing (UAT) and database validation are critical QC steps, ensuring the system functions as intended before going live. 5. Smooth Trial Execution – By catching issues early, QC helps prevent costly rework, improves data quality, and ensures regulatory compliance throughout the trial. Starting strong with thorough QC sets the stage for successful data management and ensures high data quality from day one! 💡 #ClinicalDataManagement #QualityControl #ClinicalTrials #DataIntegrity #Compliance #ClinicalResearch #Datamanagement #QC #UAT #Editcheck #CDSS #EDC #Design #QualityAssurance #DataIntegrity #HealthTech #Day12 #CDM #Startupphase #Startup #pharma #Clinicalresearch #Biotech

🚀Day 10- Mastering Clinical Data Management 🚀 🌟#Understanding EditCheck Programming in the Startup Phase of Clinical Data Management🌟 In the world of clinical trials, ensuring data accuracy and consistency is paramount. That's where Edit Check Programming comes into play, especially during the startup phase of Clinical Data Management (CDM). Here’s a quick overview of what it entails: ✨What is Edit Check Programming? Edit Check Programming involves implementing automated rules that scrutinize clinical trial data for errors or inconsistencies. These checks are designed to maintain data quality by flagging discrepancies that need attention before they escalate into significant issues. 🔍Why is it Important? During the startup phase, establishing robust edit checks is crucial. It sets the foundation for high-quality data collection throughout the trial. Effective edit checks: 🚀Identify errors early: Catching issues early prevents downstream problems. 🚀Ensure protocol compliance*: Edit checks enforce the study protocol's rules and logic. 🚀Streamline data review: They reduce manual data review time, making the process more efficient. Interested in learning more about clinical data management? Connect with me or share your thoughts in the comments below. #clinicaldatamanagement #editcheckprogramming #programming #startupphase #cdm #startup #clinicaltrials #pharma #biotech #healthcare #dataquality #compliance #startup #conduct #Day10 #editcheck #effective #DataManagement #HealthcareInnovation #ClinicalTrials #cdm #dataintegrity

Our Commitment to the Highest Software Standards in Medical Technology. In medical technology, every line of code is crucial. Errors or shortcomings are not just hindrances but can be life-threatening. Hence, we commit to adhering to the highest software standards, ensuring the safety and reliability of our products. Developing medical applications requires a comprehensive understanding of legal and regulatory requirements, including aspects of quality assurance, usability, and risk control. Our rigorous internal processes ensure that each application we develop not only meets but exceeds these requirements. The importance of quality and safety in our work cannot be overstated. Lengthy development cycles with irregular tests and deployments carry a high risk of errors. We counter this risk by implementing efficient, agile methods and by continuously integrating and testing every development. This minimises the chance of errors and enables us to deliver robust and reliable medical products. Our commitment to quality is evident in every aspect of our work – from the first line of code to market launch. By adhering to the highest standards, we contribute to ensuring that medical products are not only effective but also safe. Follow us to learn more about how our dedication to quality and safety can shape and improve medical technology. #SoftwareQuality #MedTechSafety #Innovation #HivemindTechnologies #devops #kubernetes

Hey LinkedIn fam! After years in the medical lab world, working on cell processing in cGMP labs and ensuring strict regulatory compliance, I’m ready to channel my skills into a new direction – as an Epic Analyst. I’m passionate about contributing to seamless healthcare operations and bringing my background in lab data management and process optimization to the tech side of healthcare. 🌟 Here’s what I bring to the table: • Regulatory Expertise: Skilled in maintaining compliance with industry standards, including rigorous data accuracy and quality control in healthcare environments. • Technical Skills: Hands-on experience with flow cytometry, qPCR, and advanced data analysis tools, setting a strong foundation for health IT roles. • Project Management: Adept at managing complex workflows, documentation, and communication between teams to meet project goals and enhance operational efficiency. • Process Improvement: Proven track record in problem-solving and creating streamlined systems in fast-paced, high-stakes settings. I’m eager to apply these skills in a new capacity and contribute to healthcare organizations by ensuring seamless Epic system functionality and supporting critical workflows. If you know of any openings or have advice on navigating this exciting transition, I’d love to connect! #EpicAnalyst #HealthcareIT #DataManagement #JobSeeking #HealthcareTransformation