Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a division of the Miltenyi 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.Associate Clinical Data Management Director Waltham, MAYour Tasks:As a member of the Miltenyi Biomedicine team, you will be responsible for Miltenyi Biomedicine (MBM) data management practices to support our US-specific hybrid insource-outsource data management approach. Additionally, you will work with internal Miltenyi Biomedicine the data management team to help ensure internal Miltenyi and CRO adherence to data management processes, communicate data standards, and establish/ oversee Sponsor-CRO data management key performance indicators (KPIs). As a result of your ability to represent Data Management on cross-functional teams, you will support the continued success of Miltenyi Biomedicine as a whole.Essential Duties and Responsibilities:
- Work 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.
- 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.
- Ensure that 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:
- A minimum of 5 years' experience in data management within a sponsor organization with lead experience; or equivalent combination of education and experience.
- Oncology and cell therapy experience highly desirable.
- Prior GCP training and understanding of industry best practices to support drug development programs and submissions through BLA/ MAA are required.
- 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.
- Experience with multiple EDC systems, through full development life cycle.
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 25 pounds. Specific vision abilitiesrequired 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. Must be able to travel routinely by car and plane.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 variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit clinical trial sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs must be followed and PPE may be required to be worn per Miltenyi or hospital policies.Miltenyi Biomedicine is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth. We empower great science. For more than 35 years, Miltenyi has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 2,000 scientists, engineers, physicians, support specialists, marketers, and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender IdentityMiltenyi Biotec, Inc. participates in E-Verify.