Clinical Research Scientist

Description

The Clinical Research Scientist leads the execution of the clinical studies that make up the company's clinical evidence generation program. In this role, you will execute clinical studies and / or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

The Clinical Research Scientist collaborates closely with cross-functional teams, including Medical Scientists, Biostatistics & Data Management, Medical Writers, and Marketing to generate impactful clinical evidence that supports the company's strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape.

This position can also be located in Durham, North Carolina

Primary Duties

Contributes to the development and leads the implementation of study strat egy with internal stakeholders

Contributes to the development of the study synopsis

Leads the development of study plan for non-registrational studies (Simple)

Leads the development of BIR / CIR study proto cols for non-registrational studies (Simple)

Review IIR study proto cols

Lead site selection activities

Serves as G lobal Medical Affairs point of contact with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies

Functionally responsible for all clinical monitoring activities throughout study

Manages clinical study agreements

Manages the coordination of logistics and training needed to execute studies

Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders

Assures clear external / internal team communication, process documentation, and compliance with BMX and departmental processes along with GCP

Contributes to the assessment of processes and establishing plans for improvements

Manage s IIR study execution / follow-up with little to no supervision

Define and manage study budget

Accountable for the delivery of documentation to meet study milestones

Coordinates the creation of the study database / CRF and reviews data / analysis with cross-functional teams

Contributes to or leads the development of study abstract and / or poster in collaboration with internal stakeholders

Contributes to peer-reviewed journal publication of study results in collaboration with internal stakehold ers

All other duties as assigned.

Experience

Ba chelor's degree in a life science field (biology, chemistry, medical / clinical laboratory technologist etc. ) required

Master ' s or PhD preferred

5+ years of experience conducting in vitro diagnostics and / or medical device clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation and delivery of clinical studies.

Experience with the management of timelines, deliverables, and milestones

Experience with budget oversight, risk mitigation, and clinical data review

Understands the US and European Medical Testing environments and relevant professional societies and guidelines ( e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.)

Proven track record of writing clinical study plans and study protocols

Knowledge, Skills & Abilities

Strong computer skills including word processing and use of spreadsheets . Skills with database and project management software desirable.

Demonstrate ability to work collaboratively with various stakeholders in a highly matrixed global environment

Good communication skills

#LI-US

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https : / / careers.biomerieux.com / or contact us at [emailprotected] .

BioMerieux Inc. and its affiliates are Equal Opportunity / Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected] , or by dialing 711 for access to Telecommunications Relay Services (TRS).