Note: The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully-integrated life sciences services organization dedicated to accelerating customer success in drug development. The Senior Clinical Scientist in Clinical Surveillance & Training will contribute expertise in protocol design, training, and analysis, ensuring the effective administration of clinical scales and supporting business development activities.

Responsibilities

• Contributes to draft protocol review, scale selection, and may contribute to full protocol design and development, offering clinical expertise and partnering with customers on design and specific text Participates in the development of eligibility review, endpoint review, rater qualification, training, and certification plans, documents, reports, etc
• Contributes to scales management and translations deliverables Reviews case report forms and electronic clinical outcome assessment (eCOA) pages to ensure consistency between the database and original scale, and provides feedback to team Works with vendors and/or Company staff involved in training regarding the use of clinical scales, diagnostic instruments, or provision of (eCOA) technology
• Provides internal Syneos Health and site staff training on therapeutic indications, scale administration, and scale scoring
• Performs clinical and statistical analysis of rating scale, and/or endpoint data Works with Investigators and their staff in order to ensure that they understand the specifics of the protocol, particularly surrounding entry criteria, diagnostic scales, and clinical scales In collaboration with Medical Directors, reviews screening data and leads case reviews to determine whether subjects are appropriate for entry into a trial
• Provides professional, collaborative, and scientific feedback to investigators
• May perform final review and quality control check of documents and materials drafted by other CST members Continuously improves clinical and scientific expertise through research and publication
• Maintains familiarity with current relevant literature
• Provides scientific and clinical expertise to Sponsors, study teams, and the Company
• May serve as indication and CST service subject matter expert Supports business development activities by providing scientific proposal text, protocol considerations and/or slides
• May participate in bid defense meetings
• May contribute to strategic CST process improvement, team growth, and infrastructure development
• Provides CST-specific training and support to other CST members in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training May line manage and/or mentor other CST members

Skills

• Contributes to draft protocol review, scale selection, and may contribute to full protocol design and development, offering clinical expertise and partnering with customers on design and specific text
• Participates in the development of eligibility review, endpoint review, rater qualification, training, and certification plans, documents, reports, etc
• Contributes to scales management and translations deliverables
• Reviews case report forms and electronic clinical outcome assessment (eCOA) pages to ensure consistency between the database and original scale, and provides feedback to team
• Works with vendors and/or Company staff involved in training regarding the use of clinical scales, diagnostic instruments, or provision of (eCOA) technology
• Provides internal Syneos Health and site staff training on therapeutic indications, scale administration, and scale scoring
• Performs clinical and statistical analysis of rating scale, and/or endpoint data
• Works with Investigators and their staff in order to ensure that they understand the specifics of the protocol, particularly surrounding entry criteria, diagnostic scales, and clinical scales
• In collaboration with Medical Directors, reviews screening data and leads case reviews to determine whether subjects are appropriate for entry into a trial
• Provides professional, collaborative, and scientific feedback to investigators
• May perform final review and quality control check of documents and materials drafted by other CST members
• Continuously improves clinical and scientific expertise through research and publication
• Maintains familiarity with current relevant literature
• Provides scientific and clinical expertise to Sponsors, study teams, and the Company
• May serve as indication and CST service subject matter expert
• Supports business development activities by providing scientific proposal text, protocol considerations and/or slides
• May participate in bid defense meetings
• May contribute to strategic CST process improvement, team growth, and infrastructure development
• Provides CST-specific training and support to other CST members in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
• May line manage and/or mentor other CST members

Benefits

• A company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time
• Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements

Company Overview

Company H1B Sponsorship