Associate Dir/Dir of Clinical Data Mgmt (DG)
Job Location: Northern, NJ
Associate Director / Director of Clinical Data Management
Pharmaceutical/Biotechnology, Northern NJ
Small pharmaceutical firm that is growing and fast paced, looking for an Associate Director or Director to help lead all the data management functions to ensure that clinical studies are properly designed and presented to support the product development and the resulting regulatory submissions. Level depends on experience.
Serve as the expert in Clinical Data Management to provide information to the clinical project team regarding data management activities and deliverables. Manage and resolve issues related to data management deliverables and represent the Data Management team during any vendor interaction.
In this role, he/she will be responsible for the following:
Supervise studies, EDC databases and medical coding. Oversee external data management / integrations data and development of reporting tools. Manage PK data and operational logistics. Drive overall strategy within Data Management including standards and process. Identify and implement new technology to support the development of Clinical Data Management and clinical studies. Provide expertise in the contract process for any Data Management related activities and oversight of Data Management related vendor contracts, outsourcing and budgets. Manage and develop staff and resources. Implement and manage early phase clinical studies and lead the Clinical Study Teams and CROs in meeting study deliverables and timelines. Collaborate with others to support cross-functional initiatives and process optimization as well as support cross-functional teams in identifying risks and metrics monitoring.
Must have minimum BS degree in Life Science, Health, or related area from accredited college or university. Advanced degree preferred. Minimum of 7-10 years working in Data Management within the Biotech/Pharma/CRO industry. For Associate Director level, must have strong hands on experience plus minimum 4 years management or overseeing others. For Director level, minimum 8 years of line management and project team leadership experience, as well as process management and innovation. Experience with clinical trials leading to NDA submissions and prior engagement with NDA eSubmission. Strong technical and problem solving skills as well as excellent written and verbal English communications skills, including presentation skills. Must have strong team management skills and proven ability to manage multiple projects, set priorities and meet deadlines. Ability to work well on a team and independently. Ability to work under pressure and handle multiple assignments at once. MSOffice skills including Word, Excel, PowerPoint, Outlook.
Please contact Darren Gutowski at firstname.lastname@example.org
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