418 Study Start Up Lead jobs found with companies that value diversity

Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services.

Execute Clinical and analytical testing in the US to support product development for new Hematology and Hemostasis products(reagents and analyzers). Works with R&D, Clinical and Regulatory in the US and France to verify and validate that new products meet pre-defined specifications and requirements, the intended use, user needs, and requirements in the real-world operational environment as well as U.S. regulatory requirements. Provides comprehensive knowledge of instrument operation in support of clinical validation. Delivers a comprehensive overview of various lab and clinical trials and research projects as needed.

Essential Duties & Responsibilities

Stays current with product and instrument capabilities in order to advise the organization regarding important scientific developments as well as creating and maintaining a scientific and technical relationship with opinion leaders.
Maintain awareness of new and updated testing standards in order to provide support to clinical trial designs and execution.
Interacts with groups, such as but not limited to CLSI, CLIA and CAP in order to ensure Stago is at the forefront of the market's evolution
Works closely with the NCRA to help support validation trials in the US in support of new Hematology and Hemostasis products and parts.
Works closely with French counterparts to help conduct and support verification activities as well as clinical validation activities in the US in facilitation of new Hematology and Hemostasis product launches.
Verify technical conditions prior to the start of a study, ensure instruments are in pristine working order and maintenance
of equipment is up to date to ensure successful study conditions.
Ensures full understanding of the protocol requirements to ensure the study proceeds efficiently in order to meet organizational
time lines.
Participates in the development of study related materials needed to execute verification and validation studies and may periodically be required to lead these efforts
Assist with the execution of clinical and analytical studies to support new and existing products and reports results to all external stakeholders (biologists, clinicians, lab techs)
Ensures a field presence during validation study activities and may be a point of contact for the external sites participating in the studies.
Verify the technical conditions of study staff prior to the start of study, conduct necessary training of personnel and ensure maintenance of equipment is up to date for successful study conditions.
Ensure corrective actions are followed for proper conduct to freeze databases of results in accordance with the studies initial objectives.
Check completeness of records (all forms of media: paper and electronic), ensures centralization and formatting of data from studies, as well as ensuring traceability of data
Uses knowledge and experience with instrument validation to perform interference, on-board stability, real-time-stability, Limit of Blank, Limit of Detection, Limit of quantification, Linearity, precision and Method Comparison testing.
Utilizing local members of the service operations, create good logistical conditions for verification and validation studies to include but are not limited to delivery of reagents and/or instrument, exchange of correspondence, contracts and administrative documents.
Ensures successful protocol implementation and monitors analytical protocol execution to ensure the quality of the study data as well as the study proceeding efficiently in order to meet organizational timelines.
Documents all necessary follow-up to study in accordance with defined procedure including but not limited to monitoring plan, checklist of setting up visits, monitoring, etc.
Enters data into databases, online systems, or other means depending on the study designs, as needed
Issues queries to resolve errors and missing data
Collects agreements, records, labels, forms, study reports or other study documentation as applicable.
Maintain laboratory equipment following daily, weekly and monthly maintenance schedules as well as required quality control for all laboratory analyzers.
Participates in validation of new equipment as appropriate
Assists the NCRA's in the development and maintenance of clinical study binders and utilization of eCRF.
Manages the Laboratory equipment service contracts and documentary elements of verification and validation studies.
Completes the necessary documentation and reports for verification/validation studies performed in the laboratory.
Completes necessary clinical trial documentation from the site's perspective, in preparation of study start up, if required.
Give scientific presentations as required.
Offer support on new product launches as needed.

Qualifications

B.S. Medical Technology/Clinical Laboratory Science or equivalent from an accredited four-year college or university required; MT(ASCP) Certification or equivalent preferred; Minimum of two years experience as a Technical Support Specialist or Field Support Engineer with Hematology and Coagulation instrumentation required, external or Stago experience, or minimum five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations and training lab staff on new laboratory instrumentation.
Experience designing, organizing, and conducting clinical trials is a plus.
Demonstrated competency in the review of statistical analysis methods for clinical data is a plus.
Experience in IVD product development is a plus.
To perform this job successfully, an individual should be familiar with Excel and Windows Office Suite Applications and other company software.
ASCP preferred.
Ability to read, analyze and interpret complex documents; respond effectively to technical inquiries and customer complaints. Ability to write and deliver effective and persuasive technical and non-technical presentations to senior management, sales and service staffs, and customer representatives. Ability to work with mathematical concepts such as probability and statistical inference.
Up to 50% U.S. travel required during execution of studies.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer an extensive benefit and compensation package that includes medical, dental, vision, FSA, 401k, PTO, life and disability insurance, as well as a comprehensive leave program. Pay anticipated for this position in New Jersey is from $68,000-88,000, depending on a number of factors. This role is also anticipated to be eligible to participate in a bonus plan and an automobile plan which are associated with this position. In the ordinary course of business, compensation and benefits programs may change based upon the Company's needs.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

See job description