Clinical Scientist - future roles (US)

Job Responsibilities

• 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, spreadsheets, presentations.
  • PREFER KNOWLEDGE OF DRUG DEVELOPMENT AND DEMONSTRATED PROFICIENCY WITH ICH/GCP GUIDELINES.
  • Strong team player with excellent interpersonal skills and ability to work effectively in a cross-functional team environment.

    Benefits

    • 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.