Manager, Clinical Data Management

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Everest Clinical Research

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

Gegründet 2004

💊 Pharmazie

🧬 Biotechnologie

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research ist eine globale Clinical Research Organization (CRO), die umfassende Dienstleistungen im Bereich klinische Studien und Biometrics-Expertise für Pharma- und Biotechnologie-Sponsoren bietet. Das Unternehmen offeriert klinische Operationen und Projektmanagement, risikobasiertes Qualitätsmanagement und zentralisiertes Monitoring, medizinisches Monitoring, Pharmakovigilanz, klinisches Datenmanagement, Biostatistik und statistische Programmierung, regulatorische Strategie und Einreichungen sowie Technologielösungen wie IRT/RTSM und ePRO/eCOA. Everest positioniert sich als ein qualitativ hochwertiger Partner mit globaler Reichweite und therapeutischer Expertise in den Bereichen Onkologie, Neurologie, Atemwegserkrankungen, seltene Krankheiten und Immunologie.

Beschreibung

• Work with a Director and/or Senior Director of Clinical Data Management to manage clinical trial programs/projects from one or multiple clients. • Provide day-to-day technical and operational leadership to project teams supporting these programs/projects. • Manage client accounts and perform client relationship management. • Function as a technical and operational leader, serve as a Principal level Lead Data Manager for individual clinical trials or a program of clinical trials, lead data management teams, interact with clients and/or Everest internal project leaders to plan and implement data management project plans, and generate and deliver quality data management deliverables. • Mentor and develop staff members as well as team members supporting projects with oversight responsibilities. • Review data management deliverables generated by the teams and provide review comments to ensure overall satisfactory team performance and quality delivery. • Perform regular one-on-one meetings, performance reviews, and evaluation of staff members. • Participate in data management project budget planning, tracking, and reporting. • Develop and manage data management resource plans and perform ongoing assessment and control for the utilization of resources. • Assist with integrating the operations of Clinical Data Management with the requirements of other functional service teams to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management. • Assist with performing competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used in the unit are the best in the class. • Participate in the planning, development, and maintenance of Clinical Data Management governing documents in line with industry good data management practices in CRF design, database definition, data processing, and data management. • Participate in, and contribute to, the corporate efforts in investigating, establishing, and implementing new and advanced systems, standards, and procedures to improve the effectiveness and efficiency of clinical data management. • Contribute to organization development and growth by participating in the interview and evaluation process for job candidates. • Assist in business development activities, including but not limited to, the following: provide cost estimates of data management services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.

🎯 Anforderungen

• A B.Sc. or higher in Biological Science, Computer Science, Biostatistics or Mathematics • Eleven (11) years’ related experience • A comprehensive knowledge of the systems, programs, and operations required to collect, store, QC, and process clinical data • Demonstrated ability to effectively manage medical information and organize and integrate the activities of information processing personnel • Communicate effectively, orally and in writing with personnel on all professional and administrative levels • Contribute to the investigation and implementation of new systems • Lead and direct the development and implementation of new standards and procedures to improve the effectiveness of the data management process • Participate in and contribute to the corporate efforts in establishing and implementing new systems and standards (preferred)

🏖️ Vorteile

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a pension plan • generous paid time off and sick leave • the opportunity to earn a performance based bonus