Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $109.86 - $129.25 per hour

job description

Clinical Operations

Clinical Development Scientist III

Job Responsibilities

  • Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GCDL/GDTL
  • Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
  • Provides clinical scientist input into all regulatory questions, runs ad hoc searches
  • Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
  • Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,
  • Support GDTL/GCDL to provide scientific leadership in execution of clinical trials
  • Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
  • Serve as a resource to address medical questions or clarify issues arising during conduct of the study
  • Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
  • Assist in the review, analysis and reporting of clinical trial data
  • Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
  • Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution (Director)
  • This position may be combined with the GCDL position when the program is limited in its scope and complexity (Director)
  • Collaborates with Global Development Team Lead, and Global Clinical Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent.
  • Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
  • Supports the GDTL or GCDL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
  • Assist the GDTL/GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
  • Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
  • Supports the GDTL/GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.
  • Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
  • Participates in drug safety surveillance for Development projects.
  • Act on behalf of GCDL/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Education & Qualifications

  • Bachelor's degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
  • Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
  • Demonstrated ability to collaborate in a matrixed environment
  • Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
  • Experience in designing and conducting Phase II-III clinical trials; and/or
  • Significant late-stage development research.
  • Availability to travel approximately 25% of time.
  • Availability to participate in early or late meetings/teleconferences.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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