Syneos Health
Syneos Health
Syneos Health este o organizație complet integrată de soluții biofarmaceutice, care ajută clienții să ducă terapiile de la dezvoltarea clinică până la furnizarea comercială. Echipele sale combină expertiza clinică, afacerile medicale, activitățile comerciale, tehnologia și informațiile despre piață pentru a răspunde nevoilor în schimbare din domeniul sănătății și pentru a sprijini dezvoltarea și lansarea unor tratamente importante în întreaga lume.

Lead Clinical Scientist, Gynecologic Oncology (Remote)

Lead clinical science activities for gynecologic oncology programs at Syneos Health, supporting medical data review, safety assessment, and eligibility decisions. Coordinate study teams, project deliverables, expert input, and medical review processes across integrated drug development projects.

Descriere

  • Partner with the Medical Director to create Medical Management, Medical Data Review, and Eligibility Review Plans
  • Consult external experts, advisors, and consultants to gather medical and scientific guidance
  • Conduct scheduled and as-needed medical reviews of data listings and visualizations
  • Evaluate data for risks, patterns, and trends, and document the resulting medical assessments
  • Draft medical data queries, evaluate responses, and approve query closure with the Medical Director
  • Support patient profile assessments, study-level scientific data reviews, protocol deviation reviews, and Medical Review Summary reports
  • Collaborate with Medical Directors on medical data and safety review meetings, including preparation of presentation materials
  • Oversee project scope, objectives, deliverable quality, milestones, and timelines
  • Act as the main liaison between internal teams, customers, and vendors for medical data and eligibility review activities
  • Work closely with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams
  • Detect and escalate concerns involving data integrity, subject safety, project deliverables, and scope
  • Attend and present at Trusted Process meetings and contribute to internal and external audits
  • Supervise a limited number of direct reports and participate in or lead interviews

Cerințe

  • Substantial clinical or medical science experience with deep knowledge of drug development
  • Foundational knowledge of current protocol designs
  • Foundational knowledge of disease terminology and pathology
  • Knowledge of medical data review and eligibility review processes
  • Knowledge of data listings and visualization methods
  • Knowledge of identifying data integrity and subject safety risks
  • Working familiarity with International Council for Harmonisation (ICH) guidelines
  • Working familiarity with Good Clinical Practice (GCP) standards
  • Ability to follow data privacy requirements, enterprise policies, standard operating procedures, work instructions, and project plans
  • Equivalent combinations of experience, skills, or education may be considered

Beneficii

  • Opportunities for career development and advancement
  • Supportive, engaged line management
  • Training in technical and therapeutic areas
  • Peer recognition and total rewards program
  • Company car or car allowance
  • Medical, dental, and vision coverage
  • Company 401(k) match
  • Eligibility for the Employee Stock Purchase Plan
  • Eligibility to earn commissions or bonuses based on company and individual performance
  • Flexible paid time off (PTO)
  • Sick time

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