Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a new division of the Miltenyi Biotec family focused on bringing customized cancer treatments and regenerative therapies to patients worldwide. Miltenyi Biomedicine serves an essential role in the Miltenyi Group, bridging the crucial divide from laboratory bench to patient bedside, ensuring that our innovations deliver direct benefits to those contending with some of today's most challenging diseases. Our clinical research and development team is dedicated to tailoring cell and gene therapies to individual patients, specifically working on treatments for hematological cancers using chimeric antigen receptor (CAR) T cell technology. The group is also researching regenerative therapies for Alzheimer’s disease, Parkinson’s disease, and diabetes in the elderly.
Your Tasks:
The Associate Director (AD), Clinical Data Analytics will be responsible for evaluation of our Miltenyi Biomedicine US (MBM) data management practices to optimize our “hybrid” data management model. Working with internal Miltenyi Biomedicine data management experts, the AD will ensure internal Miltenyi and CRO adherence to data management processes, communicate data standards, and establish/ oversee Sponsor-CRO data management key performance indicators (KPIs). The successful candidate will have excellent knowledge of the end-to-end clinical research and Data Management processes and may be required to serve as data management lead for one or more projects. Prior GCP training, knowledge of Good Clinical Data Management practices, and understanding of industry best practices to support drug development programs and submissions through BLA/ MAA are required.
Essential Duties and Responsibilities:
Requirements:
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.
As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.
Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Join Miltenyi Biotec and immerse yourself in an environment where you can play an integral role in improving patient care from bench to bedside.
Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity
Miltenyi Biotec, Inc. participates in E-Verify.
Click the checkbox next to the jobs that you are interested in.
Click the checkbox next to the jobs that you are interested in.
Data Quality Skill
Data Visualization Skill
Director Operational Data & Innovation
10001258 - Associate Director Insight Analyst, Boston, MA
Associate Director, Clinical Data
Clinical Dynamix, Inc., Waltham, MA