Data Management Lead
il y a 1 semaine
We are currently looking for a Data Management Lead (DML) to join the Data Management team.
The DML is accountable for all Data Management aspects of the assigned compound and/or indication from initiation till closure of activities ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.
The DML function may include Line Management responsibilities of a team of Clinical Data Managers (CDM).
Dependent on the program (phase and number of clinical trials) and the Line Management responsibilities, the DML may also act as CDM for 1 or more selected trials.
Roles & Responsibilities
The DML will:
Take a leadership role with the CRO and other internal and external partners to establish, align and conform Data Management expectations for the assigned compound and/or indication.Take a leadership role for Data Management in the Clinical Team, which is ultimately responsible to define the clinical development strategy supporting the Target Product Profile (TPP) across the lifecycle of a compound, starting with the preparation of the "First-in-Human" (FiH) clinical trial throughout "Registration" and post-approval clinical development activities.Participate in the creation and maintenance of the Clinical Development Plan (CDP) which is describing the clinical development strategy, comprising effective where possible innovative trial designs.Oversee risk identification and risk mitigation strategies for the CDP. Identify risks or deviations from plans and communicate to the Head of Data Management; to the responsible Program Leader (PL) and Management as appropriate, proactively provide solutions and oversee implementation.Set quality expectations and timelines for Data Management deliverables and will regularly follow up on Data Management milestones. Ensure inspection readiness at all times.Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.Set expectations, communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals in line with the OGSM and the cultural pillars.For the assigned compounds/indication(s) the DML will:
Oversee the CRO selection and contract negotiations.Support the Head of Data Management in keeping the oversight of the clinical budget for the assigned indication/program, collaborate with the CDMs and Statisticians to make sure the budgets are prepared, reviewed and updated within the forecast timelines as agreed with the PL and finance. Ensure that the trials and assigned clinical activities are executed within the agreed budget. Pro-actively escalate to the PL. Contribute to development of the protocol for the sections relevant for Data Management (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions.For the assigned trial(s) under the compound/indication, the DML will:
Ensure oversight of all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)Creation of essential documents (DMP, UAT documents)Creation of submission ready clinical data package per regulatory agencies requirements.Creation of archival package of clinical data per argenx requirementsEnsure oversight of all activities related to Data Management:Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data producedKeep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Head of Data Management, CDM, Data Management CRO and Clinical Team as appropriate.Ensure consistency between trials on compound/indication levelLeverages learnings and shares best practices within the indication and department.The DML will also participate in activities other than study-related:
Lead/participate in initiatives on process improvements.Participate in regulatory inspections and company audits.May include Line Management of CDMs and full on-boarding of new direct reports.Ensure that assigned staff is adequately trained and that training is documented.Mentor and enable the growth and development of assigned staff.Collaborate with Head of Data Management for own goal setting and goal review as well as of the direct reports.Skills & Competencies
Able to work effectively within a team matrix as well as independentlyStrong communication and interpersonal skillsFluent in English (written and spoken)Able to motivate and manage team members with the ability to prioritize tasks and organize workloadNatural Leader with the ability to work independently.Strong people management skills, leader and team player.Experience & Qualifications
Bachelor's degree or Master's degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experienceDemonstrated experience in Clinical Data Management and in managing CROs and vendorsBiotech experience is a plusAuto-immune and/or orphan disease clinical study background is a plusLine management experience is a plus.#LI-Onsite
-
Data Architect Lead
il y a 7 jours
Gent, Flandre, Belgique Esko Temps pleinCompany OverviewEsko is a leading provider of software, hardware and services to clients around the world, enabling them to produce the best packaging for billions of consumers.">">Job Description">">Design and oversee the data warehouse architecture and lead Business Intelligence & Analytics globally for Esko.">Combine excellent team leadership experience...
-
Data Science Team Lead and Technical Program Manager
il y a 1 semaine
Gent, Flandre, Belgique Yazzoom Temps pleinJob OverviewWe're seeking an exceptional Data Science Team Lead and Project Manager to oversee a team of data scientists and lead impactful customer projects. These include both custom AI initiatives and Yanomaly-related implementations.This role combines deep technical expertise in software and data science/ML with outstanding project and people management...
-
Team Lead, Data Engineer
il y a 1 semaine
Gent, Flandre, Belgique DSV Temps pleinTime Type: Full Time Team Lead, Data Engineer Move forward as Team Lead, Data Engineer at DSV in Ghent. About the role In this role, you will be responsible for leading a team consisting of a BI architect and data engineers. You will work closely with various departments within the organization to ensure that data engineering efforts are aligned with...
-
Unified Data Management Consultant
il y a 2 semaines
Gent, Flandre, Belgique Datashift Temps pleinJob DescriptionAs a Data Catalog Consultant, you will lead the implementation of data catalog solutions for our clients. Your primary goal will be to ensure seamless deployment and alignment with their business objectives. You will work closely with clients to understand their data management needs and provide expert advice on utilizing a data catalog to...
-
Data Architect Lead
il y a 1 semaine
Gent, Flandre, Belgique Esko Temps pleinJob OverviewEsko, a leading provider of software, hardware and services to clients around the world, enables them to produce the best packaging for billions of consumers. As the Data Architect Lead, you will be responsible for designing, implementing and maintaining the Business Intelligence (BI) roadmap in Esko using Microsoft Fabric.
-
Lead Data Analytics
il y a 4 semaines
Gent, Flandre, Belgique Amon Temps pleinEMPWR Nutrition is een internationaal toonaangevend bedrijf in de ontwikkeling en productie van hoogwaardige proteïnerepen. Wat begon in 1993 als Aminolabs, groeide uit tot een wereldspeler in gezonde snacks. Na strategische uitbreidingen en de afsplitsing als zelfstandige entiteit in 2020, heeft EMPWR zijn omzet vervijfvoudigd en zich gepositioneerd als...
-
Data Science Team Lead and Project Manager
il y a 4 semaines
Gent, Flandre, Belgique Yazzoom Temps pleinAbout us Yazzoom is a high-tech software company based in Ghent, Belgium, and a part of the global automation, digitalization, and consultancy powerhouse, ATS Corporation. We specialize in delivering AI-driven research and software solutions that help our customers optimize their production processes. Alongside our custom AI and computer vision projects,...
-
Data Science Team Lead and Project Manager
il y a 6 jours
Gent, Flandre, Belgique Yazzoom Temps pleinAbout usYazzoom is a high-tech software company based in Ghent, Belgium, and a part of the global automation, digitalization, and consultancy powerhouse, ATS Corporation.We specialize in delivering AI-driven research and software solutions that help our customers optimize their production processes. Alongside our custom AI and computer vision projects, we've...
-
Senior Data Manager
il y a 3 semaines
Gent, Flandre, Belgique Datashift Temps pleinAre you a data professional with 6 to 10 years of experience? Do you thrive on expanding domains, revolutionizing businesses, and leading and coaching a team of consultants? Are you ready to take the helm and drive success for clients within this data governance domain? If you're hungry for a real opportunity to be part of a rapidly growing consultancy firm...
-
Data & AI Manager
il y a 2 semaines
Gent, Flandre, Belgique Profacts Temps pleinProfacts is op zoek naar een Data & AI Manager die, binnen de organisatie, zal instaan voor de transformatie op vlak van data & AI. PROFACTS Profacts is een toonaangevend marktonderzoeks- en adviesbureau actief in Gent en Brussel. Als onderdeel van de Mediafin-groep in België, combineert Profacts innovatieve researchmethodes met strategisch advies om...
-
Data & AI Manager
il y a 4 semaines
Gent, Flandre, Belgique Profacts Temps pleinProfacts is op zoek naar een Data & AI Manager die, binnen de organisatie, zal instaan voor de transformatie op vlak van data & AI. PROFACTS Profacts is een toonaangevend marktonderzoeks- en adviesbureau actief in Gent en Brussel. Als onderdeel van de Mediafin-groep in België, combineert Profacts innovatieve researchmethodes met strategisch advies om...
-
data analist
il y a 3 semaines
Gent, Flandre, Belgique Datashift Temps pleinDatashift is a very fast growing consultancy team with a focus on delivering solutions that answer business questions with data and facts. For one of our fastest growing practices, we are looking for a skilled Data Catalog Consultant. As a Data Catalog Consultant, you will play a crucial role in leveraging your expertise to guide our clients in optimizing...
-
data analist
il y a 2 semaines
Gent, Flandre, Belgique Datashift Temps pleinDatashift is a very fast growing consultancy team with a focus on delivering solutions that answer business questions with data and facts. For one of our fastest growing practices, we are looking for a skilled Data Catalog Consultant. As a Data Catalog Consultant, you will play a crucial role in leveraging your expertise to guide our clients in optimizing...
-
Data Manager
il y a 2 semaines
Gent, Flandre, Belgique Datashift Temps pleinJob DescriptionAre you a data professional with 6 to 10 years of experience, thriving on expanding domains and leading teams of consultants? If so, this is your opportunity to drive success for clients within the data governance domain.Your ResponsibilitiesLead the expansion and fortification of our domain through strategic business development, creating an...
-
Data Engineer
il y a 3 semaines
Gent, Flandre, Belgique Datashift Temps pleinJob DescriptionWe are a fast-growing consultancy team focused on delivering data-driven solutions that answer business questions with facts.Your Responsibilities:Translate client needs into maintainable data solutions using ETL, Infrastructure as Code, interfaces, and pipelines.Design data solutions balancing cost and maintainability.Collaborate with Data...
-
Lead Data Science Expert and Project Implementation Specialist
il y a 2 semaines
Gent, Flandre, Belgique Yazzoom Temps pleinAbout YazzoomYazzoom is a software firm at the forefront of AI-driven innovation, delivering cutting-edge research and software solutions to boost productivity. As a key player in ATS Corporation, we empower our clients to make informed decisions through advanced analytics and actionable insights.About the JobWe're searching for a seasoned Lead Data Science...
-
Data Manager
il y a 3 semaines
Gent, Flandre, Belgique Datashift Temps pleinJob DescriptionWe are seeking a seasoned data professional with 6 to 10 years of experience to join our Datashift team as a data governance manager.About the RoleAs a data governance manager, you will be responsible for leading the change in expanding and fortifying our domain, crafting an empire of success through strategic business development. This...
-
Data Catalog Consultant
il y a 2 semaines
Gent, Flandre, Belgique Datashift Temps pleinDatashift is a very fast growing consultancy team with a focus on delivering solutions that answer business questions with data and facts. For one of our fastest growing practices, we are looking for a skilled Data Catalog Consultant. As a Data Catalog Consultant, you will play a crucial role in leveraging your expertise to guide our clients in optimizing...
-
Data Architect
il y a 3 semaines
Gent, Flandre, Belgique delaware BeLux Temps pleinData is incredibly valuable, and we're seeking visionary data architects who can design robust data frameworks, and transform raw information into powerful, innovative solutions. You'll help our customers to become truly data driven and achieve their data goals from a functional and/or technical standpoint. Sounds like you? Then let's talk What will you be...
-
Data analyst
il y a 4 semaines
Gent, Flandre, Belgique Honda Motor Europe Logistics NV Temps pleinYour job as a Data Research Analyst As part of the Business Development team in Gent, you conduct in-depth data analysis to track and report on sales and profitability evolutions for our 4 spare part divisions (Car, Motorcycle, Powerproducts and Marine). In combination with the competitor information you deliver a gap analysis and suggest areas for future...
