As a Clinical Trial Manager, you will be an integral part of the clinical research being conducted at Bodyport. Through the Bodyport platform we are seeking to improve the prediction, detection and management of cardiovascular conditions. In this role, you will oversee the planning and execution of clinical studies utilizing the Bodyport technology. 

Responsibilities:

• Oversee all operational aspects for the implementation of clinical trial activities from study start-up through database lock, ensuring that all relevant Standard Operating Procedures (SOPs) are met. Work closely with Bodyport’s product team to develop technology solutions to support the conduct of Clinical Trials.
  • Provide input for developing study-related materials, such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, training materials, and study device order forms.
  • Review monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data is delivered; coordinate with Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
  • Communicate directly with study site staff and investigators for clinical trials; track patient recruitment and progress to study timelines; monitor study budgets; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
  • Perform and oversee site monitoring visits for clinical trials as needed. Facilitate site study device orders, and ensure site accountability records are maintained.

Minimum Qualifications:

• BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
  • Experience in study project management and prior management of contracted resources/CROs.
  • At least 5 years of clinical study management experience in medical device, pharmaceutical or diagnostics industry, including 3 years of experience as a clinical study lead/project manager.

Preferred Qualifications:

• Master's degree in health or biologic science, or equivalent practical experience.
  • Experience in site monitoring and clinical quality compliance.
  • Current knowledge of FDA regulations for clinical trials.
  • Deep knowledge of the range of tools used in the clinical study management space.
  • Excellent organization and communication skills.

We want you to know:

You can be a great candidate even if you don't fit everything we've described above. You can also have important skills we haven't thought of. If that's you, don't hesitate to apply and tell us about yourself (especially in your cover letter - this is where you can really state your case).

We are committed to diversity and building an equitable and inclusive environment for people of all backgrounds and experiences, and we're taking steps to meet that commitment. We especially encourage members of traditionally underrepresented communities to apply, including women, people of color, LGBTQ people, veterans, and people with disabilities.