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The Director of Data Management Operations will provide leadership and broad oversight of Data Management Operations to ensure the integrity and quality of clinical data. This strategic leader will work alongside the Senior / Executive Director on collaborating with other departments to ensure that the company exceeds industry data and quality standards, customer expectations, and projected clinical trial data management metrics and deliverables.
The Director will interface with representatives from Biostatistics, Statistical Programming, Clinical Science, Pharmacovigilance (PV), Clinical Operations, Medical Monitoring, Medical Writing, IT, HR, Finance, Accounting, Purchasing, Legal, Recruiting. In addition, the Director will also work with CROs, partners, and external data vendors.
Leads development of the Data Management Operation's objectives aligning with Biometrics and Company's goals and develops strategic directions and plans for accomplishment. Direct all phases of the company's data management functions supporting global clinical trials including Protocol Review, Database build, CRF design, Data Entry, Data Verification, Data Review, Query Management, Coding, SAE Reconciliation, SOP Development and Training for Data ManagementKeeps abreast of literature/advancements in data collection and repository systems, data structures and industry standards (eg CDISC), computing environments, tools and products.Fosters open communications among cross-functional groups within the department as well as outside of the department to establish seamless and effective workflows.Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.Develops staff by assessing, coaching, providing appropriate training, setting goals, and recognizing those who make significant contributions to business objectives.Oversees the development of training programs to ensure that all BioMetrics personnel appropriately interpret and follow procedures.Assures that BioMetrics and non-BioMetrics Developmental Sciences staff are adequately trained on BioMetrics processes.Oversees efficient allocation of BioMetrics resources to development projects through effective budgeting and reporting processes. Develops recruitment and retention strategies in collaboration with the HR department.Plans and budgets for resource allocation and infrastructure needs. Scope This position leads Data Management Operations which is responsible for the acquisition and quality of clinical trial data which is used for review, analysis and reporting. The function supports cross-functional team members who work on new drug development programs. This position will actively participate in developing standard practices and methods for acquiring, managing and formatting of the clinical data. The position will also oversee the performance of Contract Research Organizations (CROs) and external partners engaged in Clinical Data Management ensuring that their contributions can be efficiently integrated in regulatory and publication activities.
A minimum of 15 years of technical management experience as a manager or team leader preferably in multiple areas within BioMetrics and Clinical DevelopmentExperience in coaching/mentoring both managers and individual contributors in behavioral and technical areasDemonstrated leadership abilitiesExperience with establishing department and/or project level processes and proceduresExperience with establishing partnerships with functional departments in a clinical development settingExperience in identifying and integrating new technologies and processes within and outside of the Data Management organizationExperience overseeing and establishing working relationships with vendorsCommunication at an executive level of advanced technical concepts to a non-technical audience
At least 15 years of clinical development experience (inclusive of technical and management experience within and outside of Clinical Data Management)Knowledgeable of GCP guidelinesWorking understanding of computers and databases at system level.
Project leadership of multiple research projects, often with shifting timelines, priorities and resourcesUnderstanding of the Drug Development Life Cycle and its representation in a Project Management application
Must have worked on NDA and/or BLA submissions, preferably via electronic Common Technical Document and other reporting requirementsKnowledge of US and international regulatory regulations and guidelines in drug development and approvalExperience responding to FDA and other regulatory agency requests
Must be able to build a rapport and trust with others through leadership and dependabilityMust be able to initiate clear and effective communications across disciplines or divisions in the company· Effective presentation skills
Clear, concise written and verbal communication skills
A minimum of 15 years working experience in pharmaceutical and/or Biotech Company.Thorough knowledge of new drug development processes, including data collection practices and data flow for statistical analysis.Experience working on various indications in regulatory submissions for market approvals.
Advanced knowledge of electronic data capture systems and tools· Thorough working knowledge of case report forms standardization, database design, edit checks development, data management plan development, including data specifications for the data provided by 3rd parties in clinical trials.
Ability to develop and implement high data quality control system and procedures.Ability to perform systematic data quality control management.Ability to document deliverables following procedures with the utmost rigor and attention to detail.Advanced knowledge of CDISC requirements for SDTM dataset structures.
Must possess broad understanding of computer systems.Proficiency in MS Word, Excel, PowerPoint, Visio, and Project. Education Minimum educational degree is a Bachelor of Science.Preferred educational degree is a Master in Statistics, Computer Science, or Life Science.
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