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Senior Clinical Data Management Consultant (m/f/d)

Munich, Bavaria, Germany

Job Description

Cerner Enivza are seeking a Senior Clinical Data Manager Consultant to undertake the following responsibilities:
  • ​​​​​​Management of safety relevant data, tracking and processing of safety information and maintaining Safety Data Management and Data Coding status Tracker, coding of data, Review, check, and validate safety data
  • In cooperation with management, development and proactive pursuit of specific goals in the assigned area
  • Keeping up to date with industry Data Management standards and developments and the application to appropriate systems or processes; Proactive implementation of process improvements and innovations
  • Responsible for the management of safety relevant data of clinical trials and/or non-interventional studies (NIS)
  • Maintenance of Safety Data Management and Data Coding status tracker across the projects and pro-actively communicate the progress
  • Responsible for the setup templates and project-specific safety screening specifications and safety screening plan
  • Data screening for (serious) adverse events, follow-up of (serious) adverse events, and forwarding serious adverse events to the responsible drug safety department of the Sponsor
  • Data entry of (serious) adverse event data in the safety database
  • Tracking and processing of safety information (initial and update information)
  • Identification and classification of specific events
  • Coding of data (MedDRA and WHO)
  • Creation of regular adverse event line listings
  • Review, check, and validate safety data to ensure completeness, consistency, integrity and accuracy based on project specific guidelines including query
  • Perform resp. manage (S)AE reconciliation
  • Electronic document management and maintenance of appropriate documentation
  • Cooperation on Safety Management and Data Coding process definition optimization
  • Development and maintenance of Data Management job descriptions and SOPs in the assigned area
  • Performance of Data Management activities for assigned clinical and non-interventional studies as applicable

Working Environment

Hybrid & Onsite: No Relocation Assistance Offered

This position offers a Hybrid & Onsite working environment. Meaning you will split working time between a Cerner office or client site and remote. If your current geographical location requires relocating, Cerner will not offer relocation assistance to the specified location. #LI-Hybrid

Back to Description

Because It's Personal

Time: 2:57

Additional Information

Working Environment Hybrid & Onsite: No Relocation Assistance Offered
Relocation Assistance Available for this Job: No

Qualifications

Master's/Bachelor's Degree and several years practical experience in the Clinical/Research Data Management area

Experience within a CRO, Pharmaceutical, Life Science or Medical organization

Sound stakeholder management skills

Ability to adapt and work under time pressures


All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.


Cerner is a place where people are encouraged to innovate with confidence and focus on what is important – people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.

Cerner’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.
If you are an individual with a disability who is unable to use our online tools to search and apply for jobs, and need assistance or an accommodation in the recruiting process, please contact us by calling 866-434-1543 or by emailing CernerCareers@cerner.com.

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