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Lead Data Manager

New Jersey All, NJ

Posted: 09/23/2019 Job Type: Clinical Job Number: JN -092019-25662

Assume ownership and leadership for all Clinical Data Management owned deliverables and provide leadership to respective CDM staff

Serve as the key subject matter expert on topics related to data management activities

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

Contribute to data structure standards

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

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, 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 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

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

Requirements:

The incumbent possess a high skill and knowledge level in all aspects of clinical data management in a pharma/CRO/biotech company

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)

At least 5-7 years of study and/or project level experience as a Data Manager in leading roles

Must be able to demonstrate full responsibility as the DM Lead on studies/project(s)

Deep understanding of the drug development process

Ability to work and lead effectively in a global environment


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