We realize that our success as a company depends on the experience, talents and hard work of our team members.
- Our mission is to develop and enhance therapies to treat cardiovascular diseases. Our number one priority is patient safety.
- We care deeply, work fearlessly, and change lives. We take the responsibility of the trust physicians and their patients place in us seriously and it is something that we earn each and every day.
- We work with a sense of urgency in a competitive world with limited resources at our disposal. We understand that time is money. We plan and iterate our plans continuously to enhance our efficiency and focus. We encourage brainstorming, but execution of plans are rewarded.
- We are data driven and challenge assumptions. We address the elephants in the room. We admit our mistakes and share lessons learned. We preserve the right to change our mind. We are persistently curious and humbled by what there is left to learn. We communicate with passion and clarity.
- We seek to contribute to and own technological advances, product designs, and the relationships with our customers writ broadly.
- We expect and strive to inspire the best in everyone in mind, body, and soul. We value our relationships and are positive, respectful, and open minded. We recognize the importance of family. We provide service and support to our communities as an organization and as individuals.
- We celebrate our accomplishments regularly and aim to have fun every day!
BioCardia is seeking to fill the roles listed below. Please email your resume to email@example.com.
No phone calls please.
Clinical Project Manager
ABOUT THE ROLE:
BioCardia is looking for a Clinical Project Manager to support management of a cardiovascular stem cell pivotal clinical trial in the US. The suitable candidate will work under minimum supervision and contribute technical and clinical operations expertise (including onsite and remote monitoring of clinical sites and core facilities).
In addition, the candidate will assist in the training of prospective investigators in the pivotal clinical trial and support clinical cases. Travel is anticipated to be approximately 10-40%. The candidate may potentially participate in the planning and execution of other clinical trials as well.
MAJOR DUTIES AND RESPONSIBILITIES:
- Work under minimal supervision and participate in the planning and execution of clinical trials; contribute technical and clinical operations expertise
- Perform onsite and remote monitoring of clinical sites, as assigned.
- Perform onsite and remote monitoring of third-party vendors, as assigned.
- Ensure current, accurate and complete study management/ data collection.
- Manage training and coordinating certification of study site personnel.
- Ensure site compliance with study protocol, good clinical practices, good document practices, company policies, and applicable regulations.
- Ensure current, complete and accurate filing of inhouse trial master files and of regulatory documents.
- Manage material logistics for the studies to ensure current, complete and accurate inventory and adequate study materials, including device and supplies.
- Organize investigator meetings, as necessary.
- Plan and manage pre-clinical and clinical device use training of physicians.
- Provide onsite procedural support to clinical cases as assigned.
- Perform onsite device accountability to ensure accurate inventory and adequate study materials for the cases.
- Ensure current, accurate and complete data collection forms and reports for all training sessions or clinical cases, as applicable.
- May assist with managing outsourcing services and resources from contract service providers (e.g., CRO and outsourcing providers)
- May assist with budget and contract negotiations.
- Perform other responsibilities for clinical studies as assigned.
- Travel approximately 10 - 40%.
The appropriate candidate has a Bachelor’s degree or equivalent in basic or life sciences, or a related field. An advanced degree or equivalent in life sciences or health care is preferred.
The candidate must have excellent written and verbal communications skills.
It is preferred that the candidate have approximately 50% Sr. CRA/CPM experience in trial management and 50% field support experience with device-related clinical and/or cardiovascular trials with 5 years of experience as Clinical Research Associate at a minimum.
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