Clinical Scientist in Brisbane, CA

Permanent Role

Clinical Scientist - Neuroscience/Psychiatric (Sr. Manager)

Brisbane - CA - US • Cambridge Crossing • Princeton,

Hybrid

Working with Us

• Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Client is anything but usual.
• Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
• You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
• Client recognizes the importance of balance and flexibility in our work environment.
• We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary / Objective

• Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
• May serve as Clinical Trial Lead for one or more trials
• May lead or support trial level activities for one or more trials with the necessary supervision
• May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

Position Responsibilities

• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
• Conduct literature review
• Submit clinical documents to TMF
• Develop site and CRA training materials and present these at SIVs and Investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.) 

Degree Requirements

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).  Appropriate for new entrance to pharma (post fellowship/ new to industry)

Experience Requirements

• 2+ years experience in clinical science, clinical research, or equivalent
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short range plans that are realistic and effective)
• Preferred experience in Neuroscience and/or Psychiatric

Key Competency Requirements

• Detail-oriented with commitment to quality
• Basic knowledge of disease area, compound, current clinical landscape
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Intermediate critical thinking and problem-solving skills
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

Travel Required

• Domestic and International travel may be required.

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