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Principal Clinical Data Manager

New Jersey All, NJ

Posted: 04/17/2019 Job Type: Clinical Job Number: JN -042019-24678

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 in early clinical development phases

Perform vendor selection and management

Mentor junior staff and train team members

Lead or contribute to expert working groups (e.g., QSD initiatives)

Present 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, 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)

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 DM strategic initiatives and activities

Required Qualifications:

Bachelor s Degree or higher

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

At least 2 years of experience should demonstrate full responsibility as the DM lead on studies/projects

Deep understanding of the drug development process

Possess high skill and knowledge level in all aspects of clinical data management in a clinical or research environment

Can lead a study or project data management team independently

Can lead complex projects, desire to improve best practice, and is respected as a reliable partner in Clinical Project Teams and Study Teams

Strong organizational skills an able to collaborate with minimal supervision

Ability to work and lead effectively in a global environment

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)

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