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Staff Clinical Research Studies - Cincinnati - Onsite in Cincinnati, Ohio at Mammotome

Date Posted: 1/13/2019

Job Snapshot

Job Description

Job ID: MAM000574

About Us

In December 2014, Devicor® Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients.

Devicor Medical Products, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.


Description

The Staff Clinical Studies Scientist understands business needs and follows established operating company policies/procedures and Good Clinical Practice global standards in the strategic design and oversight of assigned clinical studies. Responsible for: 
  • Leads the development and execution of the clinical evidence plan for assigned clinical studies ensuring that global market needs are designed into the plan for clinical trial investments (pre-market and post-market).
  • Represents the Sponsor in clinical study planning, trial design, trial execution and trial closeout.  Examples of work deliverables include clinical evidence strategy, clinical protocol, data management plan, monitoring plan and clinical report.  Collaborates with other functions (biostatistics, data management, regulatory, quality, R&D, etc) and external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables.
  • Operational activities supporting these clinical responsibilities require strong cross-functional collaboration.  Deliverables include: Study site qualification, site selection, site initiation, clinical study monitoring, evaluate clinical results, report generation and clinical evidence publication of trial results in peer-reviewed journals.
  • Represents the Global Clinical Affairs department on multi-functional core teams, and at FDA, to ensure program requirements are met and that clinical trials are executed in a compliant, scientifically appropriate manner. 
  • Uses the Danaher Business System and standard work to systematically measure/report/improve the overall clinical study process.  
  • Maintains current knowledge and ensures adherence to Good Clinical Practice (GCP) global standards and department standard operating procedures for conducting clinical studies.
  • Study design – diagnostic protocol writing, bio-specimen procurement, collaborate on the statistical analysis plan/data management plan, monitoring plan
  • Study conduct – management of external vendors & contract research organizations (CROs), quality and integrity of clinical data (data management), clinical study monitoring
  • Study reporting – data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications
  • May provide direction and task oversight to others on the clinical program team for one or more programs
  • Be the voice of clinical in marketing collateral review
  • Partner with marketing to create and validate compelling messages related to clinical evidence results 
  • Sit on the business unit clinical evidence steering committee
  • Review and provide clinical expertise on external proposals including response to customer on study proposals (from physicians) 
*LI-TH1.


Job Requirements



Qualifications

Education

  • Bachelor of Science (B.S.) or Master of Science (M.S.) or Doctor of Philosophy (Ph.D.). in Histology, Microbiology, Biomedical Engineering or a related field and a minimum of the following years of industry or relevant experience according to degree:
    • Bachelor’s Degree 10+ years 
    • OR Master’s degree with 7+ years
    • OR Doctoral degree with 5+ years


Skills/Experience

  • Demonstrates experience in evidence planning, clinical strategy, study design/execution and study monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment.
  • Demonstrates experience in effectively negotiating with regulators (such as the U.S. Food and Drug Administration) and designing/executing clinical programs resulting in a successful global commercial release.
  • Experience in oncology, IHC and/or ISH, or pathology imaging are highly preferred.
  • Hands-on experience with genomics and/or proteomics assay development is highly preferred.
  • Able to secure appropriate internal or external technical expertise required and coordinate efforts to resolve compliance or technical issues that may arise during clinical trials.
  • Demonstrates strong ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
  • Demonstrates strong ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities.
  • Demonstrates ability or track record of successful results, building effective teams and getting work done through others.  
  • Demonstrates ability to understand complex scientific, engineering and business concepts.
  • Proven technical writing and presentation skills required.
  • Demonstrates ability to be flexible and resourceful.  Excellent communication and diplomacy skills required.
  • Independent, motivated, organized individual with strong analytical and problem-solving skills.
  • Strong computer skills, including demonstrated high proficiency with Microsoft Word, Excel and Powerpoint
  • Demonstrates ability to apply the Danaher Business System to track/measure/report performance, solve problems and drive continuous process improvement.


Language Skills:  Must be proficient in writing, and communicating in the English language.  

Mathematical & Data Analysis Skills:  Must be consistent with claimed level of education. Knowledge of and practical experience with statistics is highly desired.

Reasoning Ability:  Good problem solving, judgment and decision-making skills are required.

Certifications, Licenses, Registrations:  Clinical research certification (such as CCRA, CCRC) is highly desired.
 

Travel: Up to 50%

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.