Sr. Clinical Research Scientist

The Opportunity

This position works out of our Pleasanton, CA location in the Heart Failure division.

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and live full lives.

The Senior Clinical Research Scientist is a member of the Global Clinical Affairs team who provides scientific expertise throughout the development and implementation of clinical evaluations, risk management and / or clinical studies.

The scientist interacts with various study support groups and cross-functional teams in order to assist in clinical and data science, clinical strategy, the development of plans and reports, and project deliverables.

The scientist is also responsible for interating with regulatory agencies as needed, and using their scientific and medical knowledge in order to provide directives to the team as well as study sites as directed by their manager.

What You’ll Work On

• Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Examine data sets and determine the best end-to-end analysis plan to address key scientific questions
• Analyzes data (including defining populations, creating model logic, drawing insights, refining analyses and determining outcomes
• Present analysis results in a cohesive manner
• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
• Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings, and regulatory agency meetings.
• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback / direction.
• Creates, manages, or participates in clinical study or clinical evaluation timelines and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Participates in and supports audits.
• Interfaces with management on significant matters, often requiring the coordination of activity across organizational units, physicians, and external CROs and medical writers.
• Participates in the development of other technical contributors by supporting training and providing feedback and guidance.
• Conducts team meetings, drafting and sending routine correspondence and presenting regular updates to senior staff.
• May participate in a project team, root cause analysis, preventive or corrective actions, and effectiveness monitoring.
• Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
• Exercises judgment independently.
• Plans and organizes project assignments of substantial variety and complexity.

Required Qualifications

• Bachelors degree in science or engineering, or related discipline
• Minimum 5 years related work experience or an equivalent combination of education and work experience

Preferred Qualifications

• Advanced Degree (PhD, MD, etc) + 2 years relevant work experience
• Strong independent data analysis and programming skills (R, SPSS, SAS, MatLab, etc.)
• Strong Data Communication and Figure Creation Experience
• Understanding of statistical principles
16 days ago