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 ❯
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 ❯
PTUC to generate high quality data for our trials. About the role: This role is integral to the DM team, and it is an excellent opportunity to utilise your clinical trial data management skills in all study types, including CTIMPs, devices and multi-site studies. Being involved at all trial stages, from protocol design to database lock. The post … holder will be responsible for designing, implementing, and maintaining database systems and resources for the recording of clinical trials data, ensuring that they are compliant with appropriate regulatory requirements. They will also work closely with PTUC's statisticians to provide support to the design, monitoring, and analysis of data sets (using R). Working as a liaison between the … SQL databases (e.g., PostgreSQL.) Experience of running web servers and data servers. Desirable Expertise in using the OpenClinica (version 3 or 4) data management system Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and data base validation. Experience working in a clinical trial setting or academic environment Demonstrable More ❯
Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages/web applications Experience in developing and delivering end user training, preferred system training Excellent interpersonal skills Good organisational and time management skills and able to demonstrate flexibility and adaptability Experience working with high volumes of documentation, electronic and paper Good attention to detail for data … entry tasks and understanding of Good Documentation … Practices A basic understanding of computer system validation in the pharmaceutical sector Experience and knowledge of working in a regulated environment, specifically with regards to record retention Knowledge of GCP and GMP with regards to QMS activities Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance 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 ❯
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 ❯
Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: We are recruiting for a Clinical Programming Portfolio Lead for our location in High Wycombe The Clinical Programming Portfolio Lead is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes … and contribute to organizational effectiveness, transparency, and communication. Directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects. In collaboration with Senior departmental leadership, the Clinical Programming Portfolio Lead influences departmental effectiveness acting as a change agent to … years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes) and regulatory guidelines (e.g., ICH-GCP) Project, risk, and team management and an established track record leading teams to successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with More ❯
Data Management Lead London Summary The Data Management Lead (DML) in pharmaceuticals Sciences is responsible for overseeing all data management activities throughout the lifecycle of clinical trials, ensuring the delivery of high-quality, reliable, and compliant clinical data. This … role involves leading data strategy development, managing timelines and deliverables. The DML ensures data collection tools, data cleaning processes, and database lock procedures are aligned with regulatory requirements (e.g. GCP, CDISC standards) and project goals. They also manage vendors and internal data teams, driving efficiency, accuracy, and innovation in clinical data handling. Key Accountabilities: Lead the development and execution … data delivery. Oversee the design, setup, and validation of clinical databases and eCRFs in alignment with study protocols and regulatory standards. Ensure all data management activities comply with GCP, internal SOPs, and industry regulations, including CDISC standards. Manage data cleaning processes, including query generation and resolution, coding, and reconciliation of third-party data sources. Act as the primary point More ❯
