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. Takes a lead role with internal and external partners and represents the company at meetings with clinical investigators and in the interaction with Contract Research Organizations (CROs) and external vendors in all aspects of data management for assigned trial(s). May provide input into CDM standards and process developments.
Assumes one or more of the following roles demonstrating the required expertise and capabilities as:
- Trial Data Manager (TDM)
- Or developing expertise and capabilities under supervision as:
- Project Data Manager (PDM), as an associate PDM or supporting a local submission (e.g. in Japan or China)
Principal Clinical Data Manager
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.
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
Principal Clinical Data Manager
- Bachelor’s degree or Master’s degree from an accredited institution (e.g. MBA, MSc) with major/focus in Life Sciences, Computer Science, Statistics, or similar preferred.
- Experience in clinical research including data management and/or clinical trial management required. Initial experience within the pharmaceutical industry, CROs or academic sites: >=6 years
- International exposure in daily business: more than 50% of international business/customers/staff over more than four (4) years.
- Technical / Analysis / Medicine:
- Technical expertise including: industry data structure knowledge (e.g. CDASH/CDISC); EDC use and database specification experience.
- Experience with data visualization/reporting, analytics; i.e. able to interpret integrated data displays and metrics identify and communicate trends.
- Experience using Statistical Analysis Software (SAS) programming and Risk Management Tools, including data review in JReview
- Ability to adapt to new technologies.
- Critical thinker and able to discern risks. Must be precise and able to detect subtle inconsistencies in data / structures.
- Planning / Organization:
- Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative.
- Must be able to work independently as well as part of a team.
- Able to effectively manage multiple assignments and adapt flexibly to changing priorities.
- Able to produce robust timelines and action plans, regularly review and follow up on progress and take decisive action in terms of follow up activities with local and global trial/project teams. Ensures work is completed effectively.
- Strong communication skills with the ability to simply summarize complex information.
- Ability to use a wide range of communication techniques and media (written and verbal). Confident and persuasive communicator to ensure that the message is clear and well understood.
- Ability to work collaboratively on multi-disciplinary project teams and to proactively manage relationships with external vendors.
- Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
- Good written and oral communication skills in the English language.
- Ability to lead and facilitate meetings.
- Ability to develop and deliver (technical) training.
- Responsible for the project collection standards, database and submission deliverables within a substance/project.
- Knowledge and experience in and continuing education of clinical trial designs, data standards, clinical trial conduct and methodology (International Conference on Harmonization (ICH) regulations.
- Good Clinical Practice (GCP), major regulatory authorities and relevant directives/regulations) are required.
- Strong project management skills and internal and external negotiation skills are required.
- Ensures all tasks are carried out in accordance with respective applicable BI Standard Operating Procedures (SOPs), BI and regulatory guidelines and BI working instructions.
Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI values.
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, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.