Posting Details
Job Details
Description
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.
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.
Associate Director, Clinical Data Management and Analytics
Waltham, MA - Remote / Flex
Your Tasks :
The Associate Director (AD), Clinical Data Management and 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 :
- Working with internal and external Data Management subject matter experts, coordinate and manage Data Management activities, timelines, and deliverables from study start to close out.
- Oversee CRO and vendors, and participate in study start-up activities, including development, review, and approval of eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation specifications and User Acceptance Testing.
- Represent Data Management on cross-functional teams.
- Remain flexible to organizational needs, explaining risks and benefits associated with possible solutions to data management challenges as they arise.
- Provide accurate study status updates, timelines, and proactive communication of Data Management risks and mitigations.
- Accountable for ensuring data quality and timelines for Data Management support organizational needs and business goals.
- Request and / or create and review project specific reports (data review listings, metrics, KPIs).
- Manage data review and query processes for inconsistencies, omissions or errors.
- Provide input to study teams on oversight documents : Data Management Plan, Clinical Monitoring Plans, Statistical Analysis Plans.
- Support Clinical Project Management on budget related activities.
Requirements :
- Bachelor’s degree; 5-10 years of experience in Data Management within a Sponsor organization with Lead experience; Or a combination of education and experience.
- Oncology and cell therapy experience highly desirable.
- Proven track record of on-time and high-quality Data Management deliverables.
- Familiarity with handling lab, centralized imaging data from external data sources
- Expertise and knowledge of industry standards (SDTM, CDASH)
- Knowledge of and experience with MedDRA and WHO Drug data dictionaries.
- Skill and knowledge in ad hoc data reporting, data review listings and metrics reporting.
- Demonstrated experience offering a range of solutions to potential Data Management challenges.
- Excellent communication skills, verbal and written.
- Organized, effective at parallel tracking Data Management tasks for multiple clinical studies at different stages of activity.
- Experience with multiple EDC systems, through full development life cycle.
- Remote / Flex - 2 days per week in office.
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.
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