​​​​​​​​​​​Job Description:

Clinical Scientist, Early Development

Research and Early Development

• The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

• Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.

• May lead or support trial level activities for one or more trials with the necessary supervision.

• 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.

• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.

• Conduct literature review.

• Develop site and CRA training materials and present these at SIVs and Investigator meetings.

• Review clinical narratives.

• Collaborate cross-functionally to monitor clinical data for specific trends.

• Contribute to the development of 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.

• Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

• Submit clinical documents to TMF.

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

• Expectation of 2+ years of 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.

• Knowledge and skills to support program-specific data review and trend identification.

• Intermediate medical writing skills and medical terminology.

• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

• Basic planning/project management skills (develop short range plans that are realistic and effective)

• Basic knowledge of disease area, compound, current clinical landscape.

• Detail-oriented with commitment to quality

• 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., patient profiles, report generating tools)

• Domestic and international travel may be required (approximately 10-20%)

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.