Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
Biomarker Trial Manager
FlexJobs Corporation
East Hanover, NJ
Apply Now >
Biomarker Trial Manager
Kelly Services, Inc.
East Hanover, NJ
Apply Now >
Biomarker Trial Manager
TechData Service Company, LLC
East Hanover, NJ
Apply Now >
Director, Global Regulatory Affairs Lead - Oncology
Merck & Co., Inc
Rahway, NJ
Apply Now >
Director, Global Regulatory Lead, Regulatory Affairs, Oncology
Merck & Co., Inc
Rahway, NJ
Apply Now >
View more jobs in Madison, NJ
View more jobs in New Jersey

Job Details

Clinical Trials Manager

Company name
C&G Consulting Services, Inc.

Madison, NJ

Apply for this job

4 hit(s)  


Clinical Trials Manager

C&G Consulting



Job #668216368

Long Term contract position available. Description: Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget). Primary responsibilities of this position include: • Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance). • Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies. • Responsible for monitoring assigned aspects of the study operational plan. • Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation • processes with input from key stakeholders. • Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness. • Responsible for supporting the management and maintenance of the study TMF. • Supports the Sr. CTM in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders. Education and Experience • Bachelors degree. • Minimum of 3 to 5 years of pharmaceuticals/biotech experience. • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. • Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech. • Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections. • Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics. • Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. • Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial. • Demonstrated experience in change management initiatives preferred. • Program and project management experience preferred. • International experience a plus. Knowledge, Skills and Abilities • Knowledge of drug development and FDA GCP/ICH regulatory guidelines. • Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. • Clinical trial management system (CTMS) background is a plus. • Strong ability to work within a matrixed organization, managing multiple tasks in a timely, budget conscious manner. • Ability to identify and work with key stakeholders to deliver operational requirements. • Ability to consistently operationalize abstract ideas. • Ability to identify issues, analyze situations and provide effective solutions. • Must possess demonstrated skill in the following: • Change Management • Decision-making, Judgment, and Problem Solving • Interpersonal relationships, team building, motivating, mentoring associates and Influencing • Initiative and Accountability • Promoting Innovation and Process Improvement • Strong oral and written communication skills. • Ability to embrace change and comfortable with ambiguity.

Updated 05/17/2018

Company info

C&G Consulting Services, Inc.
Website :

Company Profile
C&G Consulting Services is a full-service staffing company offering practical solutions to your staffing needs through contracting, contract-to-hire, and direct hire services. With 25 years of combined experience, we understand you need more than someone who simply has the ability to get the job done. You want someone you can count on to take your work as seriously as you do. Understanding your business, your culture, and your needs is our job. C&G has a network of highly qualified professionals ready to go to work for you now.

Similar Jobs:
Director Tri I TDI
Location : New York City, NY
Position Summary Provides strategic and operational leadership for a multi-institutional collaborative program for small molecule, antibody and biologics drug discovery and development within the Tri-Institutional Therapeutics Di...
Senior Clinical Study Manager
Location : Franklin Lakes, NJ
Senior Clinical Study Manager Show me jobs like this one Job Ref: R-308948 Employer: Becton, Dickinson and Company (BD) City: Franklin Lakes State: New Jersey (NJ) Position type: Full-Time Job ID R-308948 Date posted 05/17/201...
\u003Ch2 class=\iCIMS_InfoMsg iCIMS_InfoField_Job\\u003E\n\n\n\nMORE ABOUT THIS JOB\n\n\n\u003C/h2\u003E\u003Cdiv class=\iCIMS_InfoMsg iCIMS_InfoMsg_Job\\u003E\u003Cdiv class=\iCIMS_Expandable_Container\\u003E\u003Cdiv class=\iCIM...
What I liked about the service is that it had such a comprehensive collection of jobs! I was using a number of sites previously and this took up so much time, but in joining EmploymentCrossing, I was able to stop going from site to site and was able to find everything I needed on EmploymentCrossing.
John Elstner - Baltimore, MD
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
BiotechCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
BiotechCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 BiotechCrossing - All rights reserved. 21