Director Clinical Data Management *PC 1400

Your Tasks:

The role will be responsible for leading the Miltenyi Biomedicine US data management team to support our US-specific hybrid insource-outsource data management approach. The role will manage the data management team to help ensure Miltenyi and CRO adherence to data management processes, communicate data standards, and establish/ oversee Sponsor-CRO data management key performance indicators (KPIs).

Essential Duties and Responsibilities:

• Provide leadership and direction to the Data Management team, ensuring alignment with organizational goals and objectives.
• Ensure that data quality and timelines for Data Management support organizational needs and business goals. Assure adherence to SOPs and regulatory guidelines.
• Drive data standardization.
• Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs, to ensure the integrity and accuracy of clinical data.
• Collaborate with EU and global teams, align on data standards, eCRF structed, and required data management documents.
• Mentor and support data management professionals, providing guidance, training, and performance evaluations to ensure the highest level of productivity and quality.
• Lead and support the data management team with inspection readiness preparation and activities.
• Understand and streamline processes for maximum efficiency, ensuring they meet the needs of the organization and comply with industry standards.
• Monitor resource allocation and timelines to ensure successful execution of clinical data management activities.
• 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.

Requirements:

• Bachelor's degree in science or related area (or equivalent); 10+ years of experience in clinical data management in biotech/ pharma industry; significant hands-on experience in all aspects of data management; Or a combination of education and experience.
• Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials.
• 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.
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).

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 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. 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, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

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.