Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as Lead Clinical Data Manager
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Lead Clinical Data Manager, you will be responsible for:
- Working collaboratively with other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Focusing on study-start up and database amendment implementation
- Study level coordination and hands on CDM tasks, including clinical data review and reconciliation
- Oversight of external DM and data vendors
- Ensuring completeness, correctness and consistency of clinical data and data structure across projects
- Communication and escalation of study level issues including processes, timelines, resourcing, performance, etc.
- Ensuring accurate tracking and reporting of study metrics and timelines
- Communicating with functional peers regarding project status and issues and ensure project team goals are met
- Assisting in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
- Assisting with support of regulatory submission activities for assigned projects
- Providing guidance and training to CROs, vendors, investigators, and study coordinators on study requirements as applicable
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA
Required skills to have for the success of this role
· Minimum - a BS degree in a Biomedical Science or equivalent
· Minimum 5 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or bio/pharmaceutical setting
· Excellent verbal and written communication skills and interpersonal skills are required
· Ability to collaborate effectively with the study team, cross-functional team members and external partners
· Strong computer skills including knowledge of Microsoft Office Suite
· Position may require some travel
· Candidates must be authorized to work in the U.S.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date.
(Note: Accommodations may be requested for certain medical or religious reasons)
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Corindus, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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