Senior Clinical Data Manager
Your tasks and responsibilities
- Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
- Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance of Medical Standards relevant to the area of responsibility; contributes to the definition of data structure standards; review applied results of the Important Medical Event (IME) List and, medical coding conventions.
- Ensures adequate application of Data ManagementBest Practices across studies within assigned projects: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs. Incorporates and maintains Medical Standards in clinical studies and projects for all elements of the medical standards package.
- Provides governance and oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies, change orders, etc.), vendor selection and management, risk and communication management, definition of deliverables, Bayer-internal QC measures, progress tracking, and application of best data management practices.
- Advises on resource planning/allocation based on forecasted clinical activities per the Clinical Development Plan (CDP) and actual study/project metrics.
- Ensures smooth phase-transitioning of projects between research and development phases within P&O.
- Organizes state-of-the-art support for data-driven processes of interfacing business functions like Pharmacovigilance department, Pharmacokinetic department, Pharmacometrics department, and others by ensuring timely and high quality Data Management input.
- Actively supports assessment of future trends to prepare for the future , including personalized medicine, evidence based re-imbursement, smart data storage, data insights, predictive and probabilistic data management methods, digital studies, wearable devices.
- Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices
- Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.
- Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
- Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.
- Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.
Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team.
Prepares, tracks and implements standard plans (i.e., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.
Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of important deviations and validity findings, planning and conduct of interim and final Blind Review Meeting, preparation and completion of the final Blind Review Report.
Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up. Shares data arrival and cleanup status and metrics with the Study Team.
As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners.
As applicable, establishes data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions. This includes but is not limited to the following: support of setting data standards compatible with Bayer development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development.
Operational Data Management
Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.
Identifies and issue queries, incorporate query replies and track query status.
- Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR, DS&A, Portfolio & Operations, OSBU.
- Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs.
Who you are
The incumbent is a detail oriented individual with a sufficient knowledge of clinical research/development operations in order to execute relevant data management activities independently. The incumbent can lead a CDM team, and professionally contribute to project level activities.
- Bachelor’s degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject [Equivalent degrees such as state certifications/graduations might also be accepted; relevant work experience might be acceptable instead of a degree, where relevant is defined as a minimum of 10 years of relevant Data Management experience.] (not applicable for the Oncology Business Unit)
- At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles, or as a project-leading role in a scientific, data-driven position in the medical research area.
- At least 2 years of experience should demonstrate full responsibility as a Study Data Manager, or equivalent roles in in a scientific, data-driven position in the medical research area.
- Good understanding of the drug development process, understanding of relevant research processes.
- Strong organizational skills and able to collaborate with minimal supervision.
- Ability to work effectively in a global environment. Essential competencies identified include: Customer Focus, Drives Results, Plans & Aligns. Other key capabilities like Collaborates, Instills Trust, and Manages Complexity should be also displayed by the incumbent.
- Significant experience in using data management methodologies and technologies (e.g. Electronic Data Capture Familiar with data warehousing, and working in a SAS environment).
- Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]).
- The incumbent is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard.