The Specialist Data Acquisition Expert-eDC capability is a versatile experienced data management expert in Data Acquisition capability providing advanced support to trial level activities for setup and management of Electronic Data Capture. This position has expert knowledge on data acquisition related processes and technologies; will be able to independently perform work activities and take a lead role; will coach others.
This position collaborates closely within data management (e.g. DML, GDM, CDM, Process & Sourcing) to deliver on the assigned trials.
This position develops strong and productive working relationships with key stakeholders throughout the organization; Clinical teams, Global Development (e.g. PDO, IDAR, eBIS, GCO, ...), external partners (e.g. CROs, Functional Service Providers, external data vendors, technology providers, ...) and/or industry groups (e.g. Phuse, Transcelerate, ...).
This position is expected to make decisions at trial level ensuring high quality deliverables. May participate in industry work groups.
This position demonstrates strong technical skills and data scientific insights within the data acquisition capability and strong analytical / problem-solving skills to ensure high quality deliverables. He/she demonstrates project management skills.
• Execute Data Acquisition responsibilities for one or more low/moderate/high complexity trials. Take up a team lead role across compounds or disease areas or therapeutic areas.
• Provide input to clinical trial protocol, study planning, review study documents as appropriate and understand trial level requirements related to setup and management of data collection systems.
• Ensure correct adoption of clinical data standards to ensure consistency across studies, compounds, disease areas and therapeutic areas. Ensure the trial level setup & management of Electronic Data Capture systems (e.g. Medidata Rave,
...) according to best practices and defined guidelines. Including translation of eCRF specifications into eCRF layouts, fit the purpose visit schedule accommodating study design, setup and manage EDC integrations like CTMS, IWRS, Safety Gateway, setup tSDV, configure coding and data mart mappings).
• Provide oversight on external partners (e.g. CROs, Functional Service Providers, ...) who perform data management activities on Janssens behalf or by performing the data management activities internally.
• Identify and resolve issues which may negatively impact Data Acquisition deliverables within area of responsibility (study). Escalate to leadership as needed.
• Actively participate in continuous improvement initiatives; defining and implementing changes required to create an industry-leading data acquisition capability.
• High awareness of compliance requirements and compliant with company and department SOP's, policies and regulatory at any time.
• Contribute to standards development, implementation and training.
• Reports into people manager position within the functional area.
• Contacts in the organization: Clinical trial team members, including Data Acquisition Expert, Global Data Managers, Data Management Leaders, Clinical Programmer; Standards experts, eBIS system support staff.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.
Education and Experience Requirements:
• Bachelor's degree in clinical data management, relevant scientific field or equivalent work experience is required.
• Minimum of 5 Years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc.).
• Technical Data Management experience and in-depth industry standard CDASH knowledge.
• Technical Expertise in one or more of the following: eDC systems (Medidata, platform of tools), EDC integration tools, and general data capture platforms.
• Advanced project management skills and knowledge of team management principles are required.
• Demonstrated experience working with cross functional stakeholders and teams.
• Vendor management oversight experience.
• Demonstrated written and verbal communications skills.
• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.