Job: Clinical Trial Manager – US
Ablative Solutions, Inc.
More than 1 billion people have hypertension (high blood pressure). More than half the people treated for hypertension and not able to do not achieve target (control) blood pressure of 130mmHG systolic over 80mmHg diastolic.
Ablative Solutions, Inc. (ASI) has developed propriety technology to treat uncontrolled hypertension
- The Peregrine System™ Kit includes the Peregrine System™ Infusion Catheter (Peregrine Catheter) and Ablative Solutions Inc.’s Dehydrated Alcohol (ETOH).
- The minimally invasive procedure is performed under mild/conscious sedation.
- The Peregrine Catheter is advanced through a small incision in the groin and guided up to the renal arteries using angiography (X-ray with contrast). The system will deliver a small dose of dehydrated alcohol to the region just outside the artery (perivascular space), where the nerves are located, to interrupt the over-signaling of the sympathetic nervous system, that contributes to hypertension; this form of therapy is called alcohol-mediated renal denervation.
The company raised $77 million in capital in January of 2019 to develop the clinical program to obtain the CE Mark and FDA approval for the Peregrine System Kit. The company is currently conducting clinical studies in Europe and the United States to collect data in support of regulatory submissions intended to gain the above approvals and bring this therapy to market.
Position Title: Clinical Trial Manager – US
Reporting Relationship: Reports to Sr. Director, Clinical Affairs – US
FLSA Status: Exempt
As a pivotal member of the clinical team, this individual will be responsible in managing all aspects of clinical studies to ensure successful execution. Key responsibilities include, but not limited, to the following: Ensure compliance with regulatory requirements and appropriate guidance. Manage subject screening workflow. Manage consultants, Clinical Research Organization (CRO), core labs, and all other study support organizations. Prepare and track study documentations. Assist in data management activities including review of eCRF data and database report generation. Supervise study monitors and ensure their monitoring visits are scheduled based on monitoring plan. Review monitoring reports and resolve any issues with sites. Training and appraisal of trial team members. Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
- Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures, within budget and timelines.
- Participate in the design, development and review of clinical trial protocols and amendments, case report forms, study guides, and other clinical related documents.
- Must be able to understand, interpret and explain protocol requirements to others.
- Develop study-specific documents, e.g., study guides, informed consents, investigator brochures.
- Manage CROs, core labs, consultants and other vendors.
- Manage study files (Trial Master Files) and study data.
- Prepare and track subject enrollment screening, enrollment and follow-up, as well as monitoring visits.
- Develop and direct clinical study monitoring priorities and plans.
- Supervise team of Clinical Research Associates (CRA). Train and provide oversight for staff day-to-day activities.
- Participates in the recruiting and hiring process for CRAs and support their professional development.
- Provide input on clinical supplies required for the conduct of clinical trials.
- Analyze and develop action plans to address protocol compliance, data and administrative issues with investigational sites and/or regional monitors.
- Assist in Safety Management working with the CEC and DSMB as needed.
- Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
- Assist data management with report generation and database freeze lock.
- Planning and conducting investigator meetings.
- Working knowledge and experience with Word, PowerPoint and Excel.
• Bachelor’s degree, preferably in a medical-related field, with 2 to 5 years experience in Clinical Research, or equivalent. Clinical Research related professional certifications a plus.
• Experience managing study startup, monitoring, and closeout activities. Requires extensive knowledge of Clinical Research, including FDA and international regulations, GCPs, clinical trial design and documentation, and conduct of clinical trials.
• Extensive knowledge of conducting clinical
• Proficient in the application of Microsoft Word, Excel and PowerPoint and statistical software
• Effective technical writing, presentation and interpersonal skills.
• Must have the ability to managing multifaceted tasks of a clinical study.
• Excellent verbal and written communication skills.
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel within the company.
• Strong attention to detail and accuracy.
Physical Demands and Conditions Requirements:
• Travel is required.
• General office equipment.
Interested candidates should submit their resume and cover letter to: email@example.com