Randstad Clinical Operations in Lexington, Massachusetts
salary:$109.86 - $129.25 per hour
date posted:Tuesday, July 24, 2018
Clinical Development Scientist III
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.
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.