Clinical Trial Assistant (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

0.0

Posted On

13 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Attention To Detail, Organization, Communication, Teamwork, Problem Solving, MS Office, CTMS, eTMF, Hematological Studies, Oncological Studies, Autoimmune Diseases, Cellular Therapies

Industry

Biotechnology Research

Description

Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. Job Description As a Clinical Trial Assistant, you will be supporting the Clinical Trial Manager in all aspects that are required to keep the quality and timeliness of study data and communication on a high level: You support the distribution and tracking of critical clinical documents and information, e.g. essential documents, study supplies, budgets, manuals, other site and subject related information and investigational product releases in collaboration with the study team. Next this, you support the preparation and submission of study documents to IRB/IEC and regulatory authorities and assist in the collection or creation and maintenance of study startup documents, such as training materials, logs and informed consent. You coordinate the filing and reconciliation of Trial Master File documents. In addition, you support the study team by proactively identifying, resolving, and/or escalating issues to assigned staff. You assist with the creation and distribution of study-level communication to stakeholders and participate in internal team meetings, taking minutes and providing status updates. Qualifications You hold an academic degree in life sciences, natural sciences, or healthcare. You have already gained experience in clinical research as a clinical trial associate, clinical research associate and/or clinical study coordinator in the pharmaceutical/biotech industry. Attention to detail comes naturally to you as well as being highly organized. You are are used to prioritize multiple tasks, to take initiative, to work independently and to achieve project timelines. As a motivated and open-minded team player with well-developed interpersonal abilities, you enjoy working in a dynamic environment. You are naturally communicative and have effective communication (verbal and written) and organization skills, both in English and German. Ideally, you have already experience with hematological, oncological and/or autoimmune diseases clinical studies and you are interested in cellular therapies. Your proficiency in MS Office and electronic clinical trial data management systems, e.g. CTMS or eTMF, is expected. Experience in Veeva ETM and CTMS preferred. Additional Information What we offer Working with free and self-determined time management, also mobile working An intercultural environment characterized by diversity and flat hierarchies Freedom to contribute creatively and play an active role in shaping the company Individual further training in our Miltenyi University as the core of the Miltenyi DNA 30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more. Diversity is the bedrock of our creativity Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Become part of our team and focus on pushing the borders of medicine. We look forward to your application If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability. Department: Clinical Research & Development Location: Bergisch Gladbach Functional Area: Biomedicine Company: Miltenyi Biomedicine GmbH

Responsibilities

As a Clinical Trial Assistant, you will support the Clinical Trial Manager in maintaining the quality and timeliness of study data and communication. This includes distributing and tracking clinical documents, preparing submissions to regulatory authorities, and coordinating the Trial Master File documents.