Clinical Scientist

3-5 years

Not Disclosed

Titusville

10 July 4, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Job Title: Clinical Scientist (Contractor)
Company: Source One Technical Solutions
Location: Mercer County, NJ (Hybrid, mostly remote)
Duration: 6-12 months (with likely extension)
Hours: 40 hours/week, Mon-Fri
Note: No sponsorships or C2C

Job Overview

Source One Technical Solutions is seeking a Clinical Scientist for a hybrid consulting opportunity with a global pharmaceutical company. This role involves translating and implementing scientific concepts into study design and execution, integrating biomarkers, digital technologies, and data science initiatives.

Responsibilities

Program/Trial Planning, Execution, and Reporting

Translation of Scientific Concepts: Lead the translation of scientific concepts into program and study design.
Scientific Aspects: Identify and implement scientific aspects of the program/study, including integration of biomarkers and data science/digital health initiatives.
Biomarkers and Endpoints: Oversee the assessment, selection, and operational implementation of biomarkers, digital endpoints, and imaging.
DEI Strategy: Shape and implement compound and program DEI strategy with Clinical Leader.
Clinical Development Plans: Provide expert input into clinical development plans.
Documentation: Contribute to the preparation of PED, study protocols, and training materials.
Committee Meetings: Prepare for and participate in Protocol Review Committee (PRC) and First in Human (FIH) Committee meetings.
Literature Review: Review medical and scientific literature.
Study Oversight: Ensure high-quality implementation and closure of the study, ensuring data integrity.
Operational Plans: Review and sign off on operational plans.
HA and EC Responses: Provide scientific input into Health Authority (HA) and Ethics Committee (EC) responses.
Liaison Role: Act as a liaison between the company and clinical investigators for scientific guidance.
Data Management: Work with Data Sciences, Data Management, Statistics, Programming, and JJIT to ensure data quality.
Data Review: Ensure data quality and identify data quality trends.
Adjudication Activities: Set up and lead adjudication activities.
Data Visualization: Lead data visualization meetings and document decisions.
Contracting: Handle contracting with clinical consultants, IDMC members, and KOLs, including payment oversight.
Vendor Oversight: Participate in vendor oversight, focusing on data and technology integration in clinical trials.
Clinical Study Reports: Contribute to the completion of clinical study reports.
Interpretation and Reporting: Assist in the interpretation, reporting, and preparation of research results for health authority submissions.

Additional Clinical Research Responsibilities

Regulatory Strategy: Partner with Regulatory Affairs to develop regulatory strategy and determine health authority reporting requirements.
Safety Management: Oversee the setup of medical review tools and participate in data review meetings.
External Communication: Contribute to the generation and sharing of scientific data with patients and the scientific community. May act as a company spokesperson for the publication of clinical research findings and present research results at meetings.

Requirements

Degree: Bachelor's Degree in Neuroscience or related field.
Experience:
- 3-5 years of experience as a Clinical Scientist.
- Experience in pharmaceutical or clinical settings.
- Experience with planning, execution, and reporting.
- Experience with data review, study close-out, and data monitoring.
Skills:
- Integration of biomarkers and data science.
- Strong communication and data visualization skills.
- Ability to review medical and scientific literature.

Notes from Hiring Manager

Position is primarily remote but may require hybrid work (1 day onsite).
Candidate should be in the EST time zone and local to the worksite.
Role supports the Clinical Team (Neuroscience), currently conducting an MG study.
No lab experience required.

Top Skills

Data review experience
Study close-out experience
Clinical scientist experience
Data monitoring experience

For more information or to apply, please visit our website or contact us directly.

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Clinical Scientist

Job Description

Job Description

Job Overview

Responsibilities

Program/Trial Planning, Execution, and Reporting

Additional Clinical Research Responsibilities

Requirements

Notes from Hiring Manager

Top Skills

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