Senior Clinical Data Engineer
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
Job Responsibilities
-Contributes to the development process for new substances and development and promotion of drugs on the market by providing expertise, expectations, direction and oversight for Clinical Data Management (CDM) deliverables at project / trial level. Takes a lead role with internal and external partners and represents the company at meetings with regulatory authorities, clinical investigators and in the interaction with Contract Research Organizations (CROs) and external vendors in all aspects of data management for assigned project /trial(s). Provides input into CDM standards and process developments
-Assumes primary responsibilities in one or more of the following roles demonstrating the required expertise and capabilities as: Trial Data Manager (TDM) for complex trials or as subject matter expert of CDM responsibilities and processes e.g. TMCP process expert; Project Data Manager (PDM); Risk Based Quality Management (RBQM) Business Partner (BP)
Qualifications
-Education/Degree Requirements: Bachelor's degree or Master's degree (e.g. MBA, MSc)
-Major: Life Sciences, Computer Science, Statistics, or similar preferred
-Language skills & proficiency: Good written and oral communication skills in the English language
-Required capabilities (skills, experience, competencies):
1)Experience in clinical research including data management and/or clinical trial management required;
2)Initial experience within the pharmaceutical industry, CROs or academic sites: >=6 years;
3)International exposure in daily business: more than 50% of international business/customers/staff over more than 4 years;
4)One to three years of leadership experience required;
5)Technical expertise including: industry data structure knowledge (e.g. CDASH/CDISC);
6)EDC use and database specification experience, Experience with data visualization/reporting, analytics;
7)Ability to use a wide range of communication techniques and media (written and verbal).
8)Confident and persuasive communicator to ensure that the message is clear and well understood;
9)Ability to work collaboratively on multi-disciplinary project teams and to proactively manage relationships with external vendors;
10)Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively;
11)Ability to lead and facilitate meetings; Ability to develop and deliver (technical) training