Senior Scientist, Clinical Operations - Hybrid

MSDRahway, NJ
3d$117,000 - $184,200Hybrid

About The Position

This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team.

Requirements

  • Demonstrated ability to drive and manager scientific activities on clinical protocols.
  • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
  • Ability to manage multiple competing priorities with good planning, time management and prioritization skills
  • Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
  • Strong communication, technical writing, and presentation skills
  • Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management and or medical field experience OR Master’s degree + 3 years of pharmaceutical, clinical drug development, project management and/or medical field experience OR PhD / PharmD.
  • Degree in life sciences, preferred.
  • Accountability
  • Adaptability
  • Clinical Data
  • Clinical Data Interpretation
  • Clinical Operations
  • Clinical Protocol
  • Clinical Research
  • Clinical Study Design
  • Clinical Trial Compliance
  • Clinical Trial Management
  • Clinical Trials
  • Clinical Trials Analysis
  • Cross-Functional Collaboration
  • Data Analysis
  • Drug Development
  • Ethical Standards
  • ICH GCP Guidelines
  • Life Science
  • Medical Writing
  • Motivation Management
  • Parasitology
  • Prioritization
  • Regulatory Compliance
  • Regulatory Documents

Responsibilities

  • Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include Serving as the lead clinical scientist on the clinical trial team.
  • Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
  • Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
  • Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
  • Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
  • Providing tactical/scientific mentorship to other clinical scientist
  • This position may represent the company through external partnerships, collaborations, and key strategic engagements.
  • Interact with key stakeholders across department, division, and company.
  • Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
  • Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
  • Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
  • Problem solving, prioritization, conflict resolution, and critical thinking skills
  • Build team capabilities through proactive coaching

Benefits

  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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