Medical Device Clinical Trial Consultant

1 month ago

philadelphia, United States Beacon Hill Full time

Job Overview:

We are seeking a highly motivated Clinical Trial Consultant to lead and drive forward our clinical trials for wearable device technology. This role will require strategic oversight, decision-making, and hands-on involvement to ensure clinical trials proceed smoothly and efficiently. The ideal candidate will work closely with data consultants, engineers, and clinical teams, assessing real-time data to make informed adjustments to trial protocols and device performance as needed. This position is critical to aligning clinical and technical efforts, and it offers an opportunity to play a key role in the advancement of our technology.

Key Responsibilities:

  • Clinical Trial Leadership: Act as the primary driver of clinical trial execution, working with cross-functional teams to ensure all aspects of the trial are advancing effectively and in compliance with regulatory standards.
  • Data Oversight and Evaluation: Collaborate with data consultants and engineers to receive, analyze, and validate incoming trial data. Provide actionable insights and implement adjustments to the trial process as required.
  • Strategic Decision-Making: Take a proactive role in decision-making throughout the trial lifecycle, assessing data trends and making real-time adjustments to optimize trial outcomes and device performance.
  • Collaboration with Engineering: Partner closely with engineering teams to address technical issues and integrate necessary changes in response to clinical trial findings, ensuring device accuracy, reliability, and functionality.
  • Vendor and Contractor Supervision: Oversee third-party contractors and other external resources, ensuring their contributions align with project goals, timelines, and quality standards.
  • Regulatory Compliance: Manage regulatory requirements for trial data collection and submission, working to ensure the trial is in compliance with FDA regulations, ISO 13485, and other applicable medical standards.
  • Technical Guidance: Provide technical input to support the engineering and data analysis teams, helping bridge clinical needs with engineering solutions.

Qualifications:

  • Education: Bachelor’s or Master’s degree in Biomedical Engineering, Clinical Research, or a related field.
  • Experience: 5+ years of experience in clinical trials within the medical device industry, ideally with wearable technologies or remote patient monitoring.
  • Leadership and Decision-Making: Proven experience in a decision-making role for clinical trials or related projects, with the ability to make data-driven choices and lead teams effectively.
  • Data and Analytical Skills: Strong ability to interpret clinical data, assess data accuracy, and make adjustments to clinical protocols or device settings.
  • Regulatory Expertise: Solid knowledge of FDA regulations and clinical trial protocols, with experience in regulatory submissions such as 510(k) for medical devices.
  • Communication: Excellent interpersonal skills to communicate effectively with both technical and non-technical stakeholders, ensuring alignment across all involved teams.
  • Problem-Solving: Demonstrated ability to resolve complex issues in real-time and adapt to challenges that may arise during clinical trials.

Notes:

  • Location: Hybrid role based in the Philadelphia area. Onsite presence required, particularly during initial clinical trial phases.
  • Startup Environment: Candidates should be adaptable and comfortable in a startup setting, taking initiative and wearing multiple hats as needed.
  • Collaborative Role: This role will involve working closely with the CEO and key stakeholders to align clinical and business objectives.

  • Medical Device Clinical Trial Consultant

    1 month ago

    philadelphia, United States Beacon Hill Full time

    Job Overview:We are seeking a highly motivated Clinical Trial Consultant to lead and drive forward our clinical trials for wearable device technology. This role will require strategic oversight, decision-making, and hands-on involvement to ensure clinical trials proceed smoothly and efficiently. The ideal candidate will work closely with data consultants,...

  • Medical Device Clinical Trial Consultant

    1 month ago

    Philadelphia, United States Beacon Hill Full time

    Job Overview:We are seeking a highly motivated Clinical Trial Consultant to lead and drive forward our clinical trials for wearable device technology. This role will require strategic oversight, decision-making, and hands-on involvement to ensure clinical trials proceed smoothly and efficiently. The ideal candidate will work closely with data consultants,...

  • Clinical Trial Associate

    3 weeks ago

    Philadelphia, United States Meet Full time

    Clinical Trial Associate – Leading Biotech in Cardiac & Gene Therapy A pioneering biotech company specializing in cardiac gene therapy is looking for a Clinical Trial Associate to join their team. This position offers the opportunity to work with breakthrough therapies focused on transforming cardiac care for patients with severe heart conditions. As part...

  • Senior Clinical Trial Manager

    2 months ago

    philadelphia, United States Meet Full time

    One of our innovative biotech clients focused on creating gene therapies for cardiovascular diseases is seeking a dedicated Senior Clinical Trial Manager (SCTM) to lead the planning, coordination, and management of clinical trials from study start-up through to clinical study reports. If you have a passion for clinical research and a strong background in...

  • Senior Clinical Trial Manager

    2 months ago

    Philadelphia, United States Meet Full time

    One of our innovative biotech clients focused on creating gene therapies for cardiovascular diseases is seeking a dedicated Senior Clinical Trial Manager (SCTM) to lead the planning, coordination, and management of clinical trials from study start-up through to clinical study reports. If you have a passion for clinical research and a strong background in...

  • Clinical Trial Manager

    2 months ago

    philadelphia, United States Meet Full time

    We are partnered with leading Cardio and Gene Therapy biotech, in their search for a highly motivated Clinical Trial Manager to play a pivotal role in driving the successful execution of their clinical programs. Key Responsibilities:Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical trials.Develop...

  • Clinical Trial Manager

    2 months ago

    philadelphia, United States Meet Full time

    We are partnered with leading Cardio and Gene Therapy biotech, in their search for a highly motivated Clinical Trial Manager to play a pivotal role in driving the successful execution of their clinical programs. Key Responsibilities:Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical trials.Develop...

  • Clinical Trial Manager

    2 months ago

    Philadelphia, United States Meet Full time

    We are partnered with leading Cardio and Gene Therapy biotech, in their search for a highly motivated Clinical Trial Manager to play a pivotal role in driving the successful execution of their clinical programs. Key Responsibilities:Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical trials.Develop...

  • Clinical Trials Coordinator

    2 days ago

    Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

    Clinical Trials Coordinator RoleWe are seeking a highly skilled Clinical Research Nurse C to join our team as a Clinical Trials Coordinator in Philadelphia, PA. In this role, you will be responsible for implementing research protocols related to HIV, COVID-19, and other infectious diseases.The successful candidate will have a valid RN license in the State of...

  • Electrical Engineering Consultant

    2 months ago

    philadelphia, United States Beacon Hill Full time

    **This role will require full-time, on-site presence in Philadelphia for the initial 1-2 months. Following this period, the position will transition to a hybrid on-site/remote arrangement, with the possibility of becoming fully remote thereafter.**Company Overview: We are a cutting-edge technology company specializing in wearable medical devices. Our mission...

  • Electrical Engineering Consultant

    2 months ago

    Philadelphia, United States Beacon Hill Full time

    **This role will require full-time, on-site presence in Philadelphia for the initial 1-2 months. Following this period, the position will transition to a hybrid on-site/remote arrangement, with the possibility of becoming fully remote thereafter.**Company Overview: We are a cutting-edge technology company specializing in wearable medical devices. Our mission...

  • Financial Controller Clinical Trials

    7 days ago

    Philadelphia, Pennsylvania, United States Randstad Life Sciences US Full time

    Exciting OpportunityRandstad Life Sciences US is seeking a skilled Financial Controller Clinical Trials to lead the end-to-end process for clinical trial investigator grants. This role involves developing site budget templates for multiple countries and creating a total study grant forecast based on available protocol documents.About the RoleThe successful...

  • Leading Clinical Trials Expert

    5 days ago

    Philadelphia, Pennsylvania, United States Lifelancer Full time

    About this OpportunityThis is a full-time opportunity to join Clario, a leading clinical trial solutions company.Company Overview:Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what's possible.We offer competitive...

  • Manager Clinical Trial Site Budgets

    1 month ago

    philadelphia, United States Randstad Life Sciences US Full time

    Exciting Pharmaceutical Company has a contract Manager, Clinical Trial Site Budgets Position!Competitive Pay: Up to $75/HR based on experience Title: Manager, Clinical Trial Site BudgetsPosition type: This is a 6 month contract position Work Hours: Monday-Friday 8am-5pm-This will be a hybrid schedule of 2 days working onsite.Location: Philadelphia, PA...

  • Manager Clinical Trial Site Budgets

    1 month ago

    Philadelphia, United States Randstad Life Sciences US Full time

    Exciting Pharmaceutical Company has a contract Manager, Clinical Trial Site Budgets Position!Competitive Pay: Up to $75/HR based on experience Title: Manager, Clinical Trial Site BudgetsPosition type: This is a 6 month contract position Work Hours: Monday-Friday 8am-5pm-This will be a hybrid schedule of 2 days working onsite.Location: Philadelphia, PA...

  • Clinical Trial Calendar Builder

    4 weeks ago

    Philadelphia, United States Medix Full time

    Job DescriptionJob DescriptionThe Data Analyst in the Office of Clinical Research Business Operations will be responsible for completing Clinical Trial budget calendars in our clinical research software system, OnCore. This position will be in the Clinical Trials Office and works closely with, Investigators and external Sponsors to assure timely completion...

  • Scientific Leadership Position for Clinical Trials Expert

    5 days ago

    Philadelphia, Pennsylvania, United States Lifelancer Full time

    Lifelancer offers a unique opportunity for a seasoned Clinical Trials Specialist to join our team in the United States. As a Sr. Scientific Advisor, you will play a vital role in supporting Clario's electronic clinical outcome assessment (eCOA) services, providing scientific expertise and recommendations related to the sale and delivery of eCOA services.We...

  • Clinical Trials Coordinator C/D

    7 days ago

    Philadelphia, Pennsylvania, United States The University of Pennsylvania Full time

    About the RoleThe Clinical Trials Coordinator C/D position at the University of Pennsylvania involves working independently with minimal supervision. This role requires a high level of autonomy, responsibility, and expertise in managing complex clinical trials and registries. The successful candidate will work closely with physicians and research teams to...

  • Clinical Research Nurse

    3 weeks ago

    Philadelphia, United States Temple University Health System Full time

    Coordinate and facilitate the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provide leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety...

  • Cardiovascular Imaging Expert

    7 days ago

    Philadelphia, Pennsylvania, United States Lifelancer Full time

    Company Overview:Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.We are seeking an experienced Cardiovascular Imaging Expert to join our team. As a leading provider of clinical trial endpoint technology solutions, we offer...