the smart solution for Waterbury jobs

Clinical Research Scientist

Company: Beacon Hill Staffing Group - Pharma
Location: Worcester
Posted on: December 9, 2018

Job Description:

Clinical Development Scientist Primary Role: Responsible for providing scientific support for the companys 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) Responsibilities: 100%: 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 & Experience Requirements: M.D. degree (required); specialty training in Medical Genetics (preferred) Experience working in Neuroscience or Genetic Disorders is highly preferred with clinical trial experience in Rare Genetic Metabolic Diseases Generally has at least 7-10 years of experience in the Pharmaceutical Industry with relevant industry experience. Demonstrated ability to collaborate in a matrixed environment Experience in submissions of IND/CTX/NDA/BLA/MAA and interactions with Regulatory authorities Experience in designing and conducting Phase II-III clinical trials Significant late-stage development research

Keywords: Beacon Hill Staffing Group - Pharma, Waterbury , Clinical Research Scientist, Healthcare , Worcester, Connecticut

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

Healthcare Consultant Needed
Description: Start A Career Today Are you looking for a safe and legitimate way to make money from home If so, we are currently
Company: Career Division
Location: Levittown
Posted on: 12/15/2018

RN / Registered Nurse Job in East Providence, Rhode Island / Travel
Description: Psychiatric Nurse br Rhode Island br Length of Assignment: 3 months br Shift: Any br Currently looking for a Psychiatric Nurse RN in Rhode Island to provide
Company: MAS Medical
Location: East Providence
Posted on: 12/15/2018

Travel RN-Medical Surgical job in Massachusetts
Description: We are seeking an experienced and self-motivated Medical/Surgical RN to join our growing team of nursing professionals Med/Surg
Company: RNnetwork
Location: Pittsfield
Posted on: 12/15/2018

Physician: A Hospitalist is Wanted for Locums Help in NY - JOB-
Description: A New York-based hospital is currently seeking a hospitalist to assist with temporary locum tenens coverage. The assignment requirements include rapid response and
Company: CompHealth
Location: White Plains
Posted on: 12/15/2018

Urgent Care in Westchester County
Description: Emergency Medicine opening in White Plains, New York. This and other physician jobs brought to you by DocCafe.com We are seeking Board Eligible or Board Certified Family Medicine
Company: Clear Staffing Solutions, LLC
Location: White Plains
Posted on: 12/15/2018

Psychiatry Physician General Psychiatrist - Physicians Only Apply - Perm
Description: Medical Doctors Only Apply. A Psychiatry Physician General Psychiatrist practice is seeking a qualified physician
Company: Alpha Medical Group
Location: White Plains
Posted on: 12/15/2018

Physical Therapist Assistant Travel Job in Pittsfield, MA
Description: br We're seeking a PTA who likes to travel, has an independent or entrepreneurial spirit and who might want to gain experience helping patients recover from injuries, illnesses, and surgeries at acute (more...)
Company: Jackson Therapy Partners
Location: Pittsfield
Posted on: 12/15/2018

Seeking RN ASAP for 13-26 week contract in NY
Description: Seeking RN who can administer
Company: HumanEdge
Location: White Plains
Posted on: 12/15/2018

RN Quality/Performance Improvement
Description: Family Practice/Primary Care opening in Troy, New York. This and other rn jobs brought to you by NursingJobCafe.com Key Qualifications: Licenses Certifications: BLS, NY License, RN Minimum Education: (more...)
Company: Relode LLC
Location: Troy
Posted on: 12/15/2018

PCR Lab Technologist
Description: Full-time PCR Lab Technologist needed Reference Code: KAM Monday-Friday, day shift Position Summary: Under
Company: K.A. Recruiting, Inc.
Location: White Plains
Posted on: 12/15/2018

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

Waterbury RSS job feeds