Clinical Data Programmer/Sr. Clinical Data Programmer

Full Time Athens GA Boehringer Ingelheim

Description:

Description:

Maintain a good working knowledge of regulations, policies and guidelines applicable to the role of data management and the conduct of clinical studies within the company to support submission efforts to regulatory agencies.

Contributes to all aspects of data management tasks from clinical trial preparation to close out of study utilizing paper and or electronic format. Follow defined regulations and internal procedures to achieve high quality and accurate clinical data for submission.

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.

Duties & Responsibilities:

  • Documentation of clinical data management tasks in clinical studies according to GCP.
  • Current knowledge in Clinical Data Management trends related to Best Practice from a technical and compliance perspective.
  • Contribute to database edit checks and query specifications development, to ensure quality output.
  • Contribute to harmonization of data exchange with external cooperations, e.g. laboratories.
  • Contribute to provide written spec for loading non CRF data into the database in collaboration with programmers.
  • Control that requirements for data transfer and integration with other systems are available.
  • Contribute to the preparation of statistical data sets in the predefined format for the statistician.
  • Contributing to creation of Data Management Planning documentation including but not limited to data entry instruction and Data management plans.
  • Oversee incoming CRFs and DCFs for completion, consistency and clarity. Managing and tracking CRF flow including scanning as needed.
  • Ensure clinical project time lines are met with acceptable quality metrics, and provide appropriate communication of status, issues and risks.
The selected candidate will be hired at the appropriate level based on experience and education level. 
 
Clinical Data Programmer Requirements: 
  • Bachelors’ degree from an accredited institution in Biology and/or Computer Science is required.
  • Zero (0) to two (2) years of direct experience in Pharmaceutical industry or related field.
  • SAS and JAVA knowledge and experience a plus.
  • Ability to support multiple (5-10) clinical studies. 
  • High degree of detail orientation and excellent written and verbal communication skills.
  • Professional customer focus approach.

Sr. Clinical Data Programmer Requirements: 

  • Bachelor's degree from an accredited institution with a major focus in Data Management, Life Science, Computer Science or Math (for Germany Master degree or equivalent clinical data management experience).
  • Two to four (2-4) years of direct experience in Clinical Data Management or related field.
  • SAS and JAVA knowledge and experience a plus.
  • Ability to support/contribute multiple (1-5) clinical studies.
  • Knowledge and experience in and continuing education of clinical trial designs, data standards, clinical trial conduct and methodology VICH regulations, Good Clinical Practice (GCP), major regulatory authorities and relevant directives/regulations) are required.
  • Knowledge of Best Practice in the field of clinical data management including some knowledge in PL, SQL and statistics is preferred.
  • High degree of detail orientation and excellent written and verbal communication skills.
  • Coordinates own work and performs site-specific tasks with supervision.
  • Professional customer focus approach.
  • Responsible for the clinical trial database and the data collected within a trial/study and/or for the identification, detection and assessment of risks in a clinical trial under the supervision of a Sr. CDM or Principal CDM.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.

  • Must be willing to take a drug test and post-offer physical (if required).

  • Must be 18 years of age or older.

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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