Merit Medical Systems, Inc.
About the job
SUMMARY OF DUTIES*
Responsible for independently managing one or more long term global Patient Registries including day-to-day oversight of study vendors and study sites. Performs or oversees all Sponsor activities related to the registries and ensuring they are conducted according to relevant GCP/ICH Guidelines and applicable regulatory requirements.
Essential Functions Performed
- Develop and maintain Registry timeline.
- Develop and oversee implementation of Registry operational plan.
- Coordinate internal and external activities of Registry team members.
- Organize and coordinate training sessions at Centers of Excellences to include training physicians.
- Organize proctoring at sites.
- Train Registry sites on the protocol, case report forms (CRFs) and data entry system.
- Maintain Sponsor Trial Master File (TMF).
- Assist with creation of Registry training materials and guidelines, as appropriate.
- Create CRF completion and/or data entry guidelines.
- Serve as primary contact for all Registry sites.
- Manage all third-party vendors, including EDC vendor.
- Responsible for periodic data review to ensure high quality data is being collected.
- Responsible for monitoring of Registry site enrollment and follow-up of patients.
- Provide regular Registry status updates to senior management.
- Coordinate and/or execute all Registry deliverables, including data summaries for medical and scientific publications and required regulatory authority commitments.
- Manage budget of training, proctoring, contracts, and financial reporting for Registry.
- Coordinate Scientific Advisory Board and/or Steering Committee meetings.
- Ensure the Registry is in full compliance with all corporate and industry policies and legal and regulatory requirements, including GCPs and ICH guidelines.
- Identify project risks and suggest solutions.
- Participate in the selection of investigators and vendors.
- Receive and review all regulatory documents from sites for accuracy and compliance to Sponsor SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required.
- Mentor junior staff members.
- Performs other related duties and tasks, as required.
Summary Of Minimum Qualifications
- Education and/or experience equivalent to a bachelor’s degree in a relevant discipline.
- Three years of experience in the biotechnology, pharmaceutical or medical device industry.
- Three years of clinical project management experience, preferably with registries or observational studies.
- Current knowledge of relevant industry and regulatory compliance guidelines, including GCP and ICH guidelines.
- Knowledge of Good Clinical Practice Regulations and ICH guidelines.
- Experience with global clinical trials and vendor management.
- Experience with managing or mentoring junior staff members.
- Demonstrated knowledge of regulatory affairs.
- Demonstrated effective verbal, written, and presentation communication skills.
- Interpersonal skills, including ability to build strong working relationships and effectively manage and resolve conflict.
- Experience with electronic data capture systems.
- Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and be detail oriented.
- Experience with budget and resource management.
- Experience with vendor management.
- Proven success as a manager of people and projects.
- Experience with industry technology including Electronic Data Capture (EDC) systems and web-based communications and community tools.
- Ability to travel to clinical sites, domestic and foreign, up to 25%.
- Five years of experience in the biotechnology, pharmaceutical or medical device industry.
- Five years of clinical project management experience, preferably with registries or observational studies.
- Experience working at or with registry or clinical trial sites.
- Experience in conducting literature reviews and authoring clinical reports.
- Clinical trials
- Management/external agency/company interaction
- Project task team participation
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled “Great people, Great products, Great Company”. Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V