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Senior Clinical Data Management Specialist

Share Senior Clinical Data Management Specialist Job ID:
151951 Career Level:
Experienced Location:
United States of America (Connecticut)Ridgefield Function:
Medicine / Regulatory Affairs Schedule:
Full-Time 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 carrying this function acts as Trial Data Manager for one or more trials of phase I to IV, the focus lying on complex trials within the standard setting given through BI SOPs, guidelines and working instructions.
The person carrying this function could also supervise and instruct a CRO (contract research organization) performing the tasks of the TDM.
The person carrying this function 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 Trial Data Manager (TDM) is a member of the Clinical Trial Team and is responsible for the structure of the trial database and in close co-operation with the Trial Statistician (TSTAT) and Trial Clinical Monitor (TCM) for the accuracy of the content of the trial database.
The TDM collaborates closely with the Project Data Manager (PDM) to implement project standards and a harmonized approach to all data management issues within the trial.
The Project Data Manager (PDM) is a member of the Medical Subteam and is responsible for the structure and consistency of the project database.
The PDM collaborates closely with the Trial Data Managers (TDM) to implement project standards and to ensure a harmonized approach to all data management issues.
The Specialist III, CDM can also work as a data management coach for TDMs for simple or complex trials to train them in all aspects of data management on trial level.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.
Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success.
We realize that our strength and competitive advantage lie with our people.
We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance.
Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Job Profile 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 project and BI standards.
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 of a trial.
During the conduct of the trial the TDM is responsible for data entry, getting translations from the local Clinical Monitor(s), cleaning of the data and for the reconciliation of serious adverse events (SAE) with the drug safety database according to the respective SOPs During the conduct of the trial the TDM is responsible for integration of external data from vendors or other departments into the clinical trial database.
The TDM initiates and chairs Data Quality Review Meetings in order to monitor the data throughout the conduct of the trial together with the TCM and the TSTAT.
The TDM participates in the Blinded Report Planning Meeting (BRPM), performs the final reconciliation of serious adverse events with the drug safety database and initiates and chairs the database lock meeting.
The TDM is responsible for the safety analysis of the trial data by writing validated SAS programs for analysis of demographic, treatment, adverse event, concomitant therapy and concomitant diagnosis data and by providing the trial team with the respective tables and listings on an as planned and ad hoc basis.
The PDM gives input to the core protocol, designs the project core CRFs based on the BI standard CRFs and sets up the core elements for the trial databases in the clinical data management system, incl.
the project plausibility checks.
The PDM sets up the project database to allow for across trial analyses.
In close co-operation with the PSTAT, the PDM provides displays in support of periodic update reports like Investigational New Drug (IND) annual reports and safety updates.
Requirements Bachelors (BS) in technical or health care area with minimum 3 years or Masters (MS) in quantitative field with a minimum 2 years experience in clinical data processing and thorough knowledge of clinical research.
Data processing, SAS computer programming and elementary statistics.
Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting.
Constructive interaction with inter and intradepartmental team members and personnel at other OPUs.
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.
The DMSIII with the coach function has to be experienced in the conduct of complex trials within BI.
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 olderApply NowAbout Us Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view.
Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines.
Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations.
At Boehringer Ingelheim, we are committed to delivering value through innovation.
Employees are challenged to take initiative and achieve outstanding results.
Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc.
, Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc.
, Roxane Laboratories Inc.
, Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc.
and Ben Venue Laboratories Inc.
, is an equal opportunity employer.
M/F/D/V Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.
As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Contact Boehringer Ingelheim is an equal opportunity employer.
Minority/Female/Protected Veteran/Person with a Disability.
We look forward to receiving your online application in English - please enter the Job ID 151951.
About UsBoehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view.
Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines.
Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations.
At Boehringer Ingelheim, we are committed to delivering value through innovation.
Employees are challenged to take initiative and achieve outstanding results.
Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc.
, Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc.
, Roxane Laboratories Inc.
, Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc.
and Ben Venue Laboratories Inc.
, is an equal opportunity employer.
M/F/D/V Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.
As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
ContactBoehringer Ingelheim is an equal opportunity employer.
Minority/Female/Protected Veteran/Person with a Disability.
We look forward to receiving your online application in English - please enter the Job ID 151951.


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