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 Clinical Trial Associate (CTA) will support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study.

Essential Duties and Responsibilities:

• Collaborate with Clinical Trial Manager(s) to assist in the operational and logistical aspects of clinical trial management tasks (e.g. start-up, maintenance, and close-out activities) according to ICH-GCP and standard operating procedures.
• Liaise with CROs and other clinical vendors to ensure deliverables are met and communication is efficient.
• Partner with Investigators and clinical site staff to ensure optimal Sponsor-Site relationships.
• Assist in the management of study to ensure adherence to timelines and achievement of study goals while ensuring high quality.
• Identify clinical study and investigative site risks and propose corrective actions, where applicable.
• Provide input during clinical study budget(s) reconciliation.
• Assist in the development of critical study documents.
• Review and maintain study-level training documentation.
• Review study-specific essential regulatory document packets prior to site activations.
• Acts as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the TMF
• Review TMF documents as part of the Quality Review Process; act as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection-readiness at all times.
• Obtain and disseminate schedules and calendars; prepare and distribute agenda and minutes and action items for project team meetings and client meetings.

Education and Experience

• Bachelor's Degree and 0-2 years' experience participating in clinical trial operations and/or management; or an equivalent combination of education and experience.
• Demonstrated experience supporting clinical trials.
• Knowledge of Good Clinical Practice.
• Effective oral/written communication skills used to interact with multiple stakeholders.
• Demonstrated ability to work independently and as a team member within a multidisciplinary setting.
• Effective planning, prioritization, problem solving and organizational skills, managing multiple priorities successfully.
• Competency in MS Excel, Word, and PowerPoint.
• Remote/Flex

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, or crawl. 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. This position requires up to 30% travel.

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 customer 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 and PPE must be worn. All persons performing this job will receive appropriate training prior to engaging in work requiring PPE or SOP procedures.

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

Miltenyi Biotec, Inc. participates in E-Verify.