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Jobs at Brainlab

Brainlab revolutionized digital medical technology with the introduction of software for radiosurgery and surgical navigation. Today, Brainlab is an industry leader in digital surgery, radiotherapy and integrated operating rooms.

Serving physicians, medical professionals and patients in 5,600+ hospitals in 116 countries, we’re transforming healthcare to improve the lives of patients everywhere.

We employ over 1,500 people in 20 offices worldwide. Close-knit teams made of talented, curious and authentic people are working together toward a common goal.

Brain-Pulse is a start-up division of the Brainlab family, headquartered in Riem, Munich, with employees also residing in the United States. We are using non-invasive brain accelerometry to measure a completely new biological signal. This signal serves as an input for diagnosing various brain anomalies, such as stroke. The device is intended to be used as a tool for triaging and/or monitoring. Our aim is to profoundly impact patient care by saving time in diagnoses and paving the way for better patient outcomes.

Together we’re dedicated to making an impact.

Sound like you?

Join and grow with us.

Clinical Research and Data Manager - Boulder, CO or Chicago, IL

  • Boulder, United States
  • Full-time
  • Department: Support Other

WHAT TO EXPECT

The Clinical Research & Data Manager will oversee the clinical research function and resulting data from studies. The manger will report to the Director of Marketing & Clinical Research and collaborate effectively with various groups within the organization to ensure study success. This role can be located in Boulder, CO or Chicago, IL.

  • Successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables
  • Overseeing each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication skills between study sites and sponsor
  • Working closely with the Marketing, Research & Development and Regulatory teams
  • Assisting with IRB submissions or providing the necessary paperwork to local IRBs for their submissions
  • Writing or contributing to clinical protocols, informed consent forms, amendments, study guides, case report forms, and any other clinical research related documents
  • Manage CTMF organization, filing and maintenance of documents
  • Overseeing performance of CROs, monitors and other third-party clinical vendors to ensure compliance with study protocol and in accordance with scope of work
  • Managing CRAs through scheduling, training, and all monitoring activities
  • Receiving and performing initial review of CRO and other third-party study vendor invoices
  • Tracking progress of all clinical studies and providing timely updates to management
  • Managing site initiation visits and any other interim site training, data collection, or troubleshooting that is needed, including planning, preparation and execution
  • Ensuring studies are carried out according to the study protocol, SOPs, and latest applicable regulations and guidelines (e.g. ISO, FDA, MDR)
  • Managing receipt, entry, and maintenance of CRFs, device recording files, clinical data workbooks and Electronic Data Capture system
  • Maintain clinical databases and create queries and reports
  • Listing, reporting and maintaining all studies on clinicaltrials.gov
  • Assisting in abstract and manuscript writing to meet submission deadlines for various publications and conferences
  • Managing the maintenance, preparation, and logistics of the device systems used in clinical research studies

WHAT YOU OFFER

  • At least 3 years of clinical trial management experience in the medical device industry, preferably in management of multiple clinical trials at one time,
  • Certified Clinical Research Professional (CCRP) Certification is desired,
  • Demonstrated knowledge of clinical trial management including all guidelines and IRB requirements,
  • Knowledge of industry Data Management standards and practices,
  • Experience with Electronic Data Capture (EDC) systems is preferred,
  • Advanced relationship skills: Ability to develop strong partnerships with clinical sites and key opinion leaders,
  • Excellent communication/presentation skills,
  • 5-10% travel for site initiation visits or other occasional on-site meetings at clinical sites

WHAT WE OFFER

In return for the experiences listed above we will provide a business casual environment, competitive compensation package including medical, dental, life, LTD, STD, and matching 401k benefits and much more.

Visit us at: www.brainlab.com

Brainlab, Inc. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Covid-19 vaccination, subject to legally allowed exemptions, required based on Brainlab’s Federal contractor status and in compliance with Presidential Executive Orders.

Brainlab participates in E-Verify. Click here for more information. Click here to also review the EEO Law Poster. 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected]

Apply now