(Senior) Clinical Project Coordinator (f/m/d)

BD; Karlsruhe; Vor Ort; EUR 53.000 - 81.000; Vollzeit

Zusammenfassung

BD Karlsruhe seeks an organized Clinical Product Management support professional to enable successful execution of BDPI studies. You will handle study supplies, TMF maintenance, and CTMS data integrity across domestic and international locations.

The role requires a life sciences degree, 1+ years in clinical research, and strong MS Office skills. Join a global leader delivering transformative healthcare solutions with a collaborative, detail-driven team.

Qualifikationen

• Bachelor’s Degree in life sciences or equivalent related experience.
• 1+ years of clinical research or lab/medical device experience.
• Proficiency with Microsoft Office and collaborative tools.

Aufgaben

• Provide operational support for BDPI clinical studies to enable successful completion of study objectives and deliverables.
• Prepare and ship clinical study supplies and investigational products to domestic and international sites.
• Serve as a Clinical Product Management expert for BD stakeholders, Investigators, and study site personnel.
• Support Clinical Project Management and Site Management & Monitoring with administrative tasks as needed.
• TMF maintenance and audits to ensure study files are current, accurate, complete and audit-ready.
• CTMS data management to ensure site details are current and complete.
• Maintain required clinical study documents and related templates and records.
• Plan and track change control for BD QMS documentation.

Kenntnisse

Interpersonal communication

Organizational skills

Prioritization

Critical thinking

Analytical skills

Ausbildung

Bachelor's degree in life sciences

MA/MS preferred

Tools

Microsoft Office Suite

Jobbeschreibung

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities

Job Description

• Provide operational support for BDPI clinical studies to enable successful completion of study objectives and deliverables.
• Prepare and ship clinical study supplies (e.g., study binders, mini protocols, etc.) and investigational products from BD Peripheral Intervention’s headquarters to domestic and international locations for assigned clinical studies.
• Serve as a Clinical Product Management expert and resource for BD stakeholders, Investigators, and study site personnel.
• Support Clinical Project Management and/or Site Management & Monitoring with other administrative tasks (e.g., collection & upload of study documents, Confidentiality Disclosure Agreement requests, Clinical Study Agreement requests, clinical study registration updates, Purchase Order Requests, etc.) as needed, to facilitate the conduct of the study.
• Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.
• Study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.
• Clinical Product Management Plans, Clinical Product Forecasting & Tracking Templates, Clinical Site Product Accountability Logs, Clinical Product Assembly Forms, Clinical Product Inspection Forms, Clinical Product Shipment Request Forms, Clinical Site Product Receipt Confirmations, Clinical Site Product Return Records, Clinical Site Product Destruction Records, Requests for Clinical Supplier Contract Forms, Debarment Checks and other essential clinical study documents, as needed.
• Planning, tracking and management of change control requests for the maintenance of product technical documentation in BD Quality Management System (QMS)

Required Skills & Competencies

• Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
• 1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with supply inventory management/shipment, or in a clinical setting
• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
• Strong interpersonal and communication/presentation (oral and written) skills
• Strong organizational skills, attention to detail, critical thinking and analytical skills
• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects

Preferred Qualifications

• Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
• Knowledge of clinical study processes and systems (eTMF, CTMS and CEDMS). Prior experience with Veeva Vault preferred.
• 1+ years of experience with similar role for a Sponsor or Contract Research Organization (CRO)

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

DEU Karlsruhe

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

€53.200,00 - €81.100,00 EUR Annual