A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team.
As an Associate Director Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization.
You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting.
Your role: Accountable for all Clinical Data Management (CDM) related deliverables in assigned global (Phase I-IIIb) trials or programs of varying complexity Provide CDM leadership for assigned trial(s)/program(s), take global accountability and serve as the CDM representative at the study/program level Demonstrate project management and operational expertise in the strategic planning and delivery of CDM deliverables at study/program level, e.g.
planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding) Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activities Ensure quality of clinical database/deliverables (incl.
eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g.
CDISC) Act as primary point of contact within CDM for any HA submission related activities (e.g.
preparation of briefing books, attending HA meetings as requested) Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s) Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.
Lead process improvement initiatives and drive innovation in the field of Clinical Data Management Additionally, if assigned to a program: Demonstrate good understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned studies in an assigned program/indication e.g.
ensuring consistency across data quality plans Utilise understanding of CDASH and SDTM, or other recognised industry standards, to ensure consistency of implementation across studies in assigned program/indication May act as a mentor for CDM colleagues within/beyond assigned program Demonstrate willingness to take on and lead any program level activity in support of study delivery Who you are: Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, or a related field Minimum of 10 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement Proficient in contributing to non-study related initiatives e.g.
process improvements, in addition to study assignments Strong project management, analytical, communication, collaboration, and problem-solving skills Ability to work proactively and independently on assigned tasks or projects of varyingcomplexity; prioritising and managing multiple activities simultaneously Demonstrated ability to lead and oversee end-to-end data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organization Familiar with autonomously providing reports to senior management, including updates on financials, forecasts and timelines Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management Experience in Risk Based Data Monitoring/Management, and with clinical trial data standards, such as CDISC, is preferred English fluent Role level: Project Manager 3 #J-18808-Ljbffr
