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Lead Data Manager

New Jersey All, NJ

Posted: 09/09/2019 Job Type: Clinical Job Number: JN -092019-25570

Assume ownership and leadership for all Clinical Data Management owned deliverable within assigned compound, projects and studies and provide leadership to respective CDM staff, interfacing functions and teams in order to support and achieve defined business goals

Serve as the key subject matter expert on topics related to data management activities including specific activities and processes

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 initiatives), presenting best practice at internal and external industry meeting/congress, and participating in due diligence assessment

Govern use of key data management element across studies in assigned projects

Assume ownership of development and maintenance Medical Standard 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 Practices across studies within assigned projects

Review Study Team documents for project consistency and ensure the adequate documentation of all data management activities according to SOP

Provide 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, internal QC measures, progress tracking, and application of best data management practice

Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP)

Key Task - Study/project metrics

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 project 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 phases in P&O, 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 practice for data generated in 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 utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up

Share data arrival and cleanup status and metrics with the Study Team while Implementing Strategy; Support the development and implementation of DMAR and/or OSBU DM strategic initiatives and activities; contribute to project and initiative aimed at improving and optimizing the delivery of DMAR

Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards

Ensure complete, accurate and timely documentation for all projects/studies according to established SOPs

Minimum Requirements:

Bachelor s degree (or higher) is required

At least 7 years of study and/or project level experience as a Data Manager in leading roles

Assume ownership and leadership for all Clinical Data Management owned deliverable within assigned compound, projects and studies and provide leadership to respective CDM staff, interfacing functions and teams in order to support and achieve defined business goals

Serve as the key subject matter expert on topics related to data management activities including specific activities and processes

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 initiatives), presenting best practice at internal and external industry meeting/congress, and participating in due diligence assessment

Govern use of key data management element across studies in assigned projects

Assume ownership of development and maintenance Medical Standard 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 Practices across studies within assigned projects

Review Study Team documents for project consistency and ensure the adequate documentation of all data management activities according to SOP

Provide 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, internal QC measures, progress tracking, and application of best data management practice

Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP)

Key Task - Study/project metrics

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 project 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 phases in P&O, 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 practice for data generated in 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 utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up

Share data arrival and cleanup status and metrics with the Study Team while Implementing Strategy; Support the development and implementation of DMAR and/or OSBU DM strategic initiatives and activities; contribute to project and initiative aimed at improving and optimizing the delivery of DMAR

Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards

Ensure complete, accurate and timely documentation for all projects/studies according to established SOPs

Minimum Requirements:

Bachelor s degree (or higher) is required

At least 7 years of study and/or project level experience as a Data Manager in leading roles

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