Senior Clinical Data Manager *PC 866

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.

Senior Clinical Data Manager

Waltham, MA

Your Tasks: 

The role will provide oversight of lead Data Manager(s) on assigned clinical data management projects in multiple clinical trial areas to ensure proper planning and execution for data management deliverables that meet Miltenyi Biomedicine standards and within timelines.

Essential Duties and Responsibilities:

• Serve as primary contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Allocates DM resources within the assigned therapeutic projects according to need and priority.
• Support a number of key stakeholders in planning and managing relevant activities within the assigned clinical trial areas for timely and quality deliverables and within the budget.
• Mentor junior data mangers for skill set advancement. If required, leads and performs clinical data management tasks for studies.
• Define requirements for collection forms for new study protocols to ensure all data required for study endpoints are collected. Perform user acceptance testing of prototype EDC and review eCRF flow dynamics and data edit specifications created by EDC vendor. Review and approve data transfer plans. Approve final EDC for all clinical trials. Monitor data collection in newly launched studies for any problems with eCRFs and work with EDC vendor to resolve any issues.
• Direct data review activities for all studies on an ongoing basis. Identify issues to check for when reviewing clinical data, direct internal and external data reviewers, and serve as a working data manager.
• Coordinate activities to lock clinical databases. Develop timelines for data cleaning, identify data review tasks, and assign and coordinate data review activities to internal and external resources. Provide programmer with requirements for data listings. Monitor the progress of source document verification and data query resolution and alert the Clinical Trial Manager of any potential problems. Maintain log of any data issues that may impact analysis of data. Approve final database lock documentation for all clinical trials. 
• Ensure real-time inspection readiness of all data deliverables for the trial; participate in Regulatory Agency and Miltenyi Biomedicine audits as necessary. 
• Work collaboratively with Clinical Trial Managers, programmers, CRAs, and others to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Take a leadership role to obtain and share best practices with internal partners. Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.

Requirements:

• Bachelor's degree in science or related area (or equivalent); At least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry, managing and coordinating data management related projects is required; 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
• Work independently and with small teams in a fast-paced, non-traditional work environment in a start-up, clinical stage biotechnology company.
•  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 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 Identity

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