Clinical Scientist – Future Roles

Role Overview

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
• Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
• Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety
• Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner
• Attends at Trusted Process meetings and may participate in internal and external audits
• Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology
• Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans
• Adheres to customer policies and standard operating procedures, as required in project plans

Requirements

• Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline
• Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment is essential
• A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work
• Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership
• Understanding of scientific principles to assure effective and high-quality medical data analysis
• Excellent written and oral communication skills
• Excellent computer skills: MS Office programs, spread sheets, presentations
• Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines
• Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment.

Tech Stack

• Google Cloud Platform

Benefits

• 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