you'll play a pivotal role in supporting QMOD-our Veeva Vault-based electronic Quality Management System (eQMS)-helping ensure it continues to meet the needs of our global clinical, regulatory, and quality functions. Whether coordinating improvements, resolving user queries, or crafting dashboards that advise strategic decisions, your contributions will support a strong quality culture across Global Development. This … partnership with Global Development IT Gathering and documenting requirements for QMOD improvements and change controls Generating reports and dashboards for audits, inspections, and quality oversight Liaising with stakeholders across Clinical, Regulatory, and Medical to understand system needs Supporting inspection readiness activities through data storytelling and reporting tools Maintaining and applying data standards for system integrity and usability Leading or … in the pharmaceutical or healthcare industry. Backgrounds in Quality Assurance, Clinical Development, or supervised IT support are all highly relevant. Familiarity with GoodClinicalPractice (GCP), Good Pharmacovigilance Practice (GVP), and the software development lifecycle for validated systems is required. Veeva Vault experience is strongly preferred. Experience generating quality reports, handling upgrades, or serving More ❯
Associate Director of Clinical Data Management Your work will change lives. Including your own. The Impact You'll Make Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You'll also play a critical role in the management of all … be responsible for leading and delivering initiatives for CDM within the Biometrics group. You'll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO's, timelines … ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables. Works with CRO and Recursion functional groups to complete EDC set up More ❯
environment. Strong project management and team leadership skills. Demonstrated ability to work independently and deliver results efficiently. Excellent understanding of EU and FDA regulations and industry standards (GMP, GLP, GCP). Proficient in Microsoft Office and other relevant IT systems. More ❯
and objectives are effectively tracked, monitored and achieved in accordance with timelines. Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. Responsible for ensuring that own training and that of the team is undertaken in a timely and … to improve and promote quality; demonstrates accuracy and thoroughness. • Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings. Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able … in parallel and working in a flexible way. • Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc. • Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred. • Must be willing to travel between the two Meiragtx sites. Why us More ❯
the standard of care, and providing personalized support and services globally. BioMarin Data Science is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, Data Science builds quality data that is fit-for-purpose to support statistically sound … GCP. The DMS Operations sub-function is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program … study team colleagues to ensure eCRF completion guidelines/instruction are accurate Develop and facilitate approval of Data Management Plan outlining key data management activities and deliverables Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan Collaborate with Clinical Programming and Database Development colleagues to ensure that database build occurs More ❯
chance to provide statistical programming solutions to HTA problems. The successful candidate will work closely with International Value & Access and HEOR teams to shape ways of working for Joint Clinical Assessment in Europe to ensure high-quality deliverables. The Senior Principal Statistical Programmer will be responsible for all statistical programming aspects of several studies, a medium to large sized … style, quality of statistical reporting & compliance with timelines. About the Role Key requirements Lead statistical programming activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. May act … including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study More ❯
either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise … effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. Comply with company, department and industry standards (e.g. … including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given More ❯
We're seeking a Digital Health Technologies (DHT) Manager to craft the future of clinical trials through innovative digital tools and technologies. In this role, you'll own the successful implementation of digital solutions-like eCOAs, eConsent, sensors, wearables, spirometry, and ECG-across clinical research studies. You'll partner closely with cross-functional teams to ensure high-quality … to make a tangible impact on how data is collected, analyzed, and used across global development. A Typical Day: Leading the implementation of digital tools for one or more clinical trials with accountability for quality and compliance Defining and supporting study-level strategies for validating and maintaining eClinical technologies Leading all aspects of digital vendor performance, including KPIs, root … Considered: You'll need proven experience with digital tools and technologies in a clinical research setting-especially eCOA systems development processes-and a strong grasp of ICH/GCP guidelines. Proficiency in project management, vendor oversight, and trial systems is required. Experience in strategic planning, partner communication, and innovation implementation is highly valued. Familiarity with Microsoft Project Server and More ❯
