
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
đĽ 13 hours ago
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Manage all data management services for assigned projects ⢠Serve as Functional Lead for Data Management and primary liaison among Data Management/Operations, Project Management, Clinical Monitoring, and other functional groups ⢠Coordinate assigned Data Management/Data Operations teams ⢠Ensure launch, delivery, and completion of Data Management activities and milestones according to contracts, SOPs, guidelines, and regulations ⢠Provide project-specific training to internal and external audiences ⢠Manage project finances, including revenue recognition, scope changes, and internal project reviews ⢠Monitor and communicate project progress to sponsors and project teams using status reports, tracking tools, and metrics ⢠Plan, manage, and request project resources ⢠Develop and maintain project plans, specifications, and documentation ⢠Maintain ongoing documentation and ensure complete, current TMF filing ⢠Participate in and present at internal, sponsor, third-party, and investigator meetings ⢠Prepare documentation for and participate in internal and external audits ⢠Train and mentor data management staff ⢠Prepare input for and participate in proposal bid defense meetings ⢠Maintain proficiency in Data Management systems and processes through regular training ⢠Perform other related duties as assigned; minimal travel may be required, up to 25%
⢠BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse; equivalent relevant work experience accepted in lieu of degree ⢠Clinical data management experience or equivalent combination of education and experience ⢠10+ years of experience in Clinical Data Management ⢠Experience leading studies and client-facing exposure ⢠End-to-end CDM experience, including setup, conduct, and closeout ⢠Rave CDMS experience ⢠Experience with Clinical Data Management practices and relational database management software systems ⢠Strong project management skills and knowledge of project management methodologies ⢠Demonstrated staff leadership skills ⢠Direct exposure to Oracle Clinical, Rave, or Inform systems ⢠Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices ⢠Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications ⢠Effective oral and written communication skills ⢠Strong presentation skills ⢠Good organizational, planning, and time management skills; ability to multitask under tight deadlines with attention to detail ⢠Ability to be flexible and adapt to change, work independently, and work as part of a multidisciplinary team ⢠Ability to make effective decisions and manage multiple priorities in a highly dynamic environment ⢠Oncology therapeutic area preferred ⢠Phase 1 and clinical pharmacology experience preferred ⢠Contract Research Organization (CRO) experience preferred
⢠Career development and progression ⢠Supportive and engaged line management ⢠Technical and therapeutic area training ⢠Peer recognition ⢠Total rewards program ⢠Inclusive culture
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đŽđł India â Remote
đ° Grant on 2023-06
â° Full Time
đĄ Mid-level
đ Senior
đ Data Scientist