Clinical Data Manager

Bayer East Hanover , NJ 07936

Posted 2 weeks ago

Principal Clinical Data Manager
Your tasks and responsibilities

The primary responsibilities of this role, “Principal Clinical Data Manager” are to:

  • Assume ownership and leadership for all Clinical Data Management owned deliverables within assigned compound, project and study and provide leadership to respective CDM (Clinical Data Management) staff, interfacing function and team in order to support and achieve defined business goals;
  • DM (Data Management) Expertise- Serve as the key subject matter expert on topics related to data management activities including specific activities and process in early clinical development phase;
  • Contribution 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 (Quality System Document) initiative), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessment;
  • PDM(Principal Data Manager)/EPDM (Early Phase Principle Data Manager) tasks- Govern use of key data management element across studies in assigned projects, assume ownership of development and maintenance Medical Standards relevant to the area of responsibility;
  • Contribute to data structure standards;
  • Review result of applied Important Medical Event (IME) List, medical coding conventions;
  • Accountable or a contributor for CDM deliverables on study and/or project level;
  • Ensure adequate application of Data Management Best Practice across studies within assigned projects;
  • Review Study Team document for project consistency; ensure the adequate documentation of all data management activities according to SOP (Standards Operating Procedures);
  • Provide governance and oversight for outsourcing activities by providing input on budgetary items (e.g. RFP (Request for Proposal) vendor costing, synergies, change orders, etc.), vendor selection and management, risk and communication management, definition of deliverables, Bayer-internal QC (Quality Check) measures, progress tracking, and application of best data management practices;
  • Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP) and actual Key Tasks and study/project metric;
  • Ensure CDM input and contribution to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans);
  • Proactive DM specific project planning and tracking (timelines, budget, risk assessment) of assigned projects from D3 to PoC and/or to submission, fully aligned with the Statistics function (2-Lead model) and the corresponding activities of the Early Clinical Team and Clinical Project Team;
  • Ensure smooth phase-transitioning of project between research and development phase in P&O (Portfolio & Operations), is instrumental to facilitate data access and exchange between research and development functions;
  • Organize 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;
  • Establish data management best practices for data generated in relevant research activities;
  • Actively support assessment of future trend 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;
  • Engage actively in ongoing data review/reconciliation activities and utilize dashboards, metrics and patient trackers to monitor data arrival and clean up;
  • Shares data arrival and cleanup status and metrics with the Study Team and Implementing Strategy;
  • *

    Support the development and implementation of DMAR (Data Management, Acqusition & Review) and/or OSBU (Oncology Business Unit) DM strategic initiatives and activities;

    *
  • Contribute to projects and initiatives aimed at improving and optimizing the delivery of DMAR. DS&A (Data Science & Analytics), Portfolio & Operations, OSBU;
  • Ensuring Compliance, perform duties in compliance with SOPs, GCP (Good Clinical Practices) and ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines in accordance with regulatory, legal and ethical standards;
  • Ensure complete, accurate and timely documentation for all projects/studies according to established SOP.
Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:



Required Qualifications:
  • The incumbent possess a high skill and knowledge level in all aspects of clinical data management in a clinical or research environment;
  • The incumbent can lead a study or project data management team independently;
  • The incumbent may lead complex projects, desire to improve best practice, and is respected as a reliable partner in Clinical Project Teams and Study Teams;
  • Bachelor’s degree (or higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subjects; [Equivalent degrees such as state certifications/graduations might also be accepted.];
  • At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles;
  • At least 2 years of experience should demonstrate full responsibility as the DM lead on studies/project(s);
  • Deep understanding of the drug development process;
  • Strong organizational skills and able to collaborate with minimal supervision;
  • Ability to work and lead effectively in a global environment;
  • Essential competencies identified include- Customer Focus, Drive Results, Manage Complexity, Plans & Aligns;
  • Other key capabilities like Collaborates and Instills Trust should be also displayed by the incumbent.

Preferred Qualifications:

  • Basic SAS Programming knowledge, or other database experience, preferred;
  • Significant experience of using data management methodologies and technologies (e.g., electronic data capture, familiar with data warehousing);
  • 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.
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