Senior Clinical Data Management (DM) Specialist or Clinical Data Management (DM) Specialist

Boehringer Ingelheim, founded in 1885 by Albert Boehringer in Ingelheim, Germany, began with just 28 people employed to manufacture tartaric acid salts. Now, more than 125 years later, the company operates globally with 146 affiliates and more than 47,000 employees.

Support of the development process for new substances and development and promotion of drugs on the market through provision of the expertise in the field of clinical data management. The person working in this function acts as Trial Data Manager for multiple trials of phase I to IV, within the standard setting given through BI SOPs, guidelines and working instructions. This person could also supervise and instruct a CRO (contract research organization) performing the tasks of the TDM or support a Project Data Manager as a Co-PDM. Alternatively the person can also act as an entry level Project Data Manager for a phase IV project (line extension or different formula for marketed substance), a project in a very early stage or of very low complexity.

* The TDM reviews the trial protocol, designs the Case Report Forms (CRF), sets up the trial database and defines and programs the plausibility checks based on BI and project standards and additional trial requirements as needed. * Together with the TCM and the TSTAT, the TDM initiates and compiles the Trial Data Management and Analysis Plan (TDMAP) that contains all the necessary BDM documentation for a trial. * During the conduct of the trial the TDM is responsible for monitoring the data entry, discrepancy managementand for cleaning (completeness, plausibility and consistency) of the data according to the respective SOPs. The TDM is responsible for integration of external data from vendors or other departments into the clinical trial database. The TDM initiates the Medical and Quality Review Plan (MQRP) and conducts Medical and Quality Review Meetings (MQRM) together with the TCM and TSTAT in order to assess patients' safety and to monitor the data flow and quality throughout the conduct of the trial. * The TDM sets up templates within J-Review to enable the trial team review of data on an aggregated level. The TDM uses the tool to get an overview of the data collected and to ensure that the data acquisition is conducted as planned. * The TDM works with the TCM, CMLs and CRA representative to ensure that the database can be locked according to the planned timelines and the planned quality. TDM is responsible for the database lock and accountable for the detection of possible data issues in the database. The TDM works with the Trial Programmer to ensure that the data extracts are usable within the programming for the trial report. * As a Co-PDM, the function holder supports an experienced PDM in the set-up of project standards, in the validation of the project database or in the monitoring of the individual trials that are part of the project. * Alternatively the function holder is a PDM for a line extension project on phase IV, thereby copying and maintaining existing standards and building on the material and documentation available. * The function holder acts as a CRO supervisor. The Sr. TDM sets up the Scope of Work for the services outsourced, performs vendor selection and qualification, develops and executes a vendor oversight plan and documents the individual steps accordingly. * Key interface as TDM is the Trial Clinical Monitor, Trial Statistician, Statistical Programmer and other Trial or Project Data Managers. Purchasing, CROs, Project team members - TMM, PDM, PSTAT, PROG. * An individual in this position is responsible for the data collected within a clinical trial. He/she represents the company at meetings with clinical investigators. Adherence to timelines and the quality of database through steering the medical and quality review process and the documentation of the processes around management of the data has a critical impact on the reputation of BI at regulatory agencies to ensure that the data acquisition happened in a scientifically valid way.

* Bachelor’s Degree in IT/IS, Mathematics or related field from an accredited institution plus 5 years’ experience within the pharmaceutical industry, CROs or academic sites * Master’s Degree in IT/IS, Mathematics or related field from an accredited institution plus 3 years’ experience within the pharmaceutical industry, CROs or academic sites * Data processing skills, technical expertise and / or programming skills and elementary statistics knowledge preferred. * Knowledge in database set-up in Oracle Clinical or Clintrial and experience with data review in JReview preferred. * Basic knowledge of medicine. * Good organizational skills, problem-solving abilities, time management skills and initiative.Flexibility and ability to work on several assignments simultaneously.Must be able to work independently as well as part of a team.Good written and oral communications skills in the English language. * Must be precise, detail oriented, and able to detect subtle inconsistencies in the data. * Continuing education in clinical trial designs and monitoring procedures, GCP and ICH regulations and clinical data processing and reporting. * Constructive interaction with inter and intradepartmental team members and personnel at other OPUs. * Ability to work successfully in global teams. **Eligibility Requirements:** * Must be legally authorized to work in the United States * Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background * Must be willing to take a drug test and post-offer physical (if required) * Must be 18 years of age or older