NewBrunswickRecruiter
the smart solution for New Brunswick jobs

Manager of Clinical Data Standards

Company: Whiz Finder Corporation
Location: New Brunswick
Posted on: April 1, 2019

Job Description:

Job Summary Title: Manager of Clinical Data Standards Company: CRO Company Location: Little Falls, NJ and/or Remote Type: Permanent Role Notes: No Corp to Corp Responsibilities: -- Ensure the Statistical Programming organization's awareness of and compliance with the latest published electronic regulatory submissions standards, including, but not limited to: - CDISC Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML. - Controlled Terminology (CT) published by CDISC, National Cancer Institute (NCI), and other organizations for use in clinical trials. - Electronic Common Technical Document (eCTD), Study Data Standards documents, and any other relevant electronic submissions guidance issued by regulatory agencies such as United States Food and Drug Administration (FDA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and others. -- Develop and maintain a library of metadata specification templates and tools to enable the efficient production of regulatory submission-compliant databases. -- Participate in ongoing review of departmental processes to ensure that deliverables are produced efficiently while remaining in compliance with regulatory submission standards. -- Review and approve the draft of SDTM and ADaM specifications prior to release of the specifications to clients and prior to production of SDTM and ADaM databases. -- Develop and deliver trainings on CDISC and regulatory submissions topics. -- Identify, train, and supervise (directly or indirectly) Clinical Data Standards experts within the Statistical Programming organization to contribute as Subject Matter Experts (SMEs) to the Clinical Data Standards objectives of the Statistical Programming organization. -- Actively participate and contribute to the Everest management team activities/function, including but not limited to the following: - Perform strategic planning and carry out plans for the continued development and improvement of overall Everest performance. - Discuss and set annual corporate level goals/objectives, enable or contribute to the achievement of these goals/objectives. - Contribute to the up-keeping of the positive, professional, high performing, and productive work environment. - Monitor and ensure compliance/adherence to corporate governing documents (policies, SOPs, Work Instructions, working Templates and Checklists). - Continue to build client relationships and grow Everest brand with them. - Perform business analysis and benchmarking in each business area as well as at the corporate level, find room for continuous improvement. Qualifications: -- Must have a M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with 6 years of clinical research experience. -- Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas. -- Requires demonstrated experiencesupporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses. -- Experience with multiple regulatory agencies preferred (FDA, PMDA, etc.). -- Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred. -- Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. -- Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts. -- Exceptional written communication and presentation skills. -- Travel level specification: this position may require up to 10% business travel.

Keywords: Whiz Finder Corporation, New Brunswick , Manager of Clinical Data Standards, Executive , New Brunswick, New Jersey

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Assistant General Manager / Assistant Manager / Restaurant Manager / Shift Supervisor
Description: The future of fast food is now, and leading the journey are our Chopt Managers - Every day, every salad, every guest, every time our Chopt Managers get it done. br br We are looking for driven Assistant (more...)
Company: Chopt Salad
Location: Paramus
Posted on: 04/27/2019

Infrastructure Management Consultant - Lifecycle Management
Description: Job Title Infrastructure Management Consultant - Lifecycle Management Location Montvale, NJ Atlanta, GA Dallas, TX St. Louis, MO Grand Rapids, MI Duration 6-12 Months Job Description Continuous assessment (more...)
Company: Xoriant Corporation
Location: Montvale
Posted on: 04/27/2019

Director of Population Health Informatics
Description: RESPONSIBILITIES Kforce has a client in search of a Director of Population Health Informatics in New York, NY. Summary The client is seeking a qualified candidate for the position of Director of Population (more...)
Company: Kforce Technology Staffing
Location: New York
Posted on: 04/27/2019


Database Release Manager with CI/CD
Description: Database Release Manager with CICD As a Release Manager you will be responsible of working on the advancement of the companyrsquos CICD processes as well as assisting in managing projects related
Company: Shulman Fleming & Partners
Location: New York
Posted on: 04/27/2019

Healthcare - Revenue Cycle Transformation Manager
Description: Health Care Revenue Cycle Transformation Manager The team - Health Care Focuses on assisting those organizations that are responsible for the delivery, funding and payment management of health care and (more...)
Company: Deloitte & Touche
Location: New York
Posted on: 04/27/2019

Associate Director of Analytics - Oncology Data
Description: Associate Director of Analytics - Oncology Data br If you are a Associate Director of Analytics - Oncology Data with experience, please read on br Top Reasons to Work with Us br We are an international (more...)
Company: CyberCoders
Location: Hoboken
Posted on: 04/27/2019

Internal Audit - Senior Manager
Description: RECRUITER: Tammy Lee br br This is an exciting opportunity for an Internal Audit Senior Manager to join our New York Internal Audit team and gain exposure to Macquarie s asset management and financial (more...)
Company: Macquarie
Location: New York
Posted on: 04/27/2019

Store Merchandising Manager - Saks Fifth Avenue New Jersey N
Description: job description br br Who We Are: br Employer is a diversified global retailer, focused on driving the performance of high quality stores and their all-channel offerings, growing through acquisitions, (more...)
Company: HBC
Location: East Rutherford
Posted on: 04/27/2019

Director, Retail Annuities Strategy
Description: A career at New York Life httpswww.newyorklife.com offers many opportunities. To be part of a growing and successful business. To reach your full potential, whatever your specialty. Above all, to make (more...)
Company: New York Life Insurance Company
Location: New York
Posted on: 04/27/2019

Digital & Cloud Enablement Change Management Consultant
Description: Digital Cloud Enablement Change Management Consultant Are you passionate about helping clients evolve their organization to adapt to and solve the complex challenges of globalization and digitalization (more...)
Company: Deloitte & Touche
Location: New York
Posted on: 04/27/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds