Specialist Study Management

7 days ago

Wilmington, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionWilmington, DEContract Duration: 12-36 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area. Candidates must be local to Wilmington, DE, non-remote position
  • Own and maintain quality for the study file as the local study team TMF owner
  • Responsible for site communications and other portal management
  • Running and analyzing reports from multiple systems
  • Responsible for Vendor Management
  • Handle requests for CTMS updates
  • Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of documents.
  • Maintain and close the local TMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
  • Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance.
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).

Experience:

  • Bachelor's Degree is preferred
  • 3-5 years of experience in Clinical Trials and Regulatory documents is required
  • Veeva experience a plus
  • Must be methodical, compliant to processes yet flexible when needed
  • High ability to manage priorities and Local Study Team expectations
  • Independent yet able to work cohesively with a team
  • Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Working knowledge of clinical study documents
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
  • Good verbal and written communication
  • Good interpersonal skills and ability to work in an international team environment
  • Willingness and ability to train others on study administration procedures
  • Display excellent organization and time management skills

  • Specialist Study Management

    7 days ago

    Wilmington, United States Artech Full time

    ***Please use the attached/revised ERMO Resume Template for resume submissions*** RECOMMENDED BILL RATE MAX: ***/HR. *You may determine the appropriate pay rate for your candidate; keeping in mind the resulting bill rate should be considered financially responsible according to your existing MSA. If you feel the recommended bill rate is not in line with...

  • Specialist Study Management

    5 days ago

    Wilmington, United States Artech Full time

    ***Please use the attached/revised ERMO Resume Template for resume submissions*** RECOMMENDED BILL RATE MAX: ***/HR. *You may determine the appropriate pay rate for your candidate; keeping in mind the resulting bill rate should be considered financially responsible according to your existing MSA. If you feel the recommended bill rate is not in line with...

  • To Go Specialist

    Found in: Lensa US P 2 C2 - 7 days ago

    Wilmington, United States RARE Hospitality Management, LLC. Full time

    For this position, pay will be variable by location - See additional job details and benefits below Great Food, Packaged with care to go with you ANYWHERE. The To Go Specialist position is all about: Ensure that we package food for convenience without compromising quality Build Guest Loyalty with order accuracy and on time delivery Focus on clean and...

  • C/S Youth Care Specialist I-III

    Found in: Talent US 2 C2 - 7 days ago

    Wilmington, United States DelDOT Full time

    Summary Statement This is the first level of work providing custodial supervision of youths to ensure the enforcement/implementation of rules and regulations affecting the care and security of youths. Essential Functions Essential functions are fundamental, core functions common to all positions in the class series and are not intended to be an...

  • Assistant Community Manager- Affordable Housing

    2 weeks ago

    Wilmington, United States Edgewood Management Full time

    Assistant Community ManagerEdgewood Management Corporation is a 50+ year old premiere affordable property management company, providing superior real estate and property management for a portfolio of over 20,000 units in many states plus the District of Columbia.  Edgewood’s portfolio represents a variety of multifamily products that include high-rise,...

  • Control Management Specialist

    3 days ago

    Wilmington, United States CareerBuilder Full time

    Control Management Specialist - RCSA (Contract) Contract (5 months 28 days) Published 2 days ago RCSA Risk Excel Title: Control Management Specialist- RCSA Location : Charlotte, NC Chandler, AZ Des Moines, IA Minneapolis, MN Duration: 6 months Benefits on offer for this contract position : Health Insurance, Life insurance, 401K and Voluntary Benefits...

  • Part-Time Accounts Payable Data Entry Specialist

    7 days ago

    Wilmington, United States Spectrum Community Management Accounting Services Full time

    Job DescriptionJob DescriptionDescription: Spectrum Accounting Plus is a dynamic business providing accounting services to other businesses throughout the US. We are dedicated to providing a higher standard of quality service to our clients with our professionalism, accountability, and commitment to excellence. Spectrum Accounting Plus is currently seeking a...

  • SY 24-25 - High School Social Studies Teacher - Special Education

    Found in: Talent US C2 - 2 weeks ago

    Wilmington, United States Red Clay Schools Full time

    OVERVIEW: The John Dickinson High School is currently seeking energetic and motivated candidates eligible for or in possession of social studies certification with dual certification in Special Education. Teacher responsible for developing and delivering instruction in both inclusive and self-contained classroom settings, manage the IEP process for a case...

  • Assistant Community Manager- Affordable Housing

    1 week ago

    Wilmington, United States Edgewood Management Corporation Full time

    Job DescriptionJob DescriptionAssistant Community ManagerEdgewood Management Corporation is a 50+ year old premiere affordable property management company, providing superior real estate and property management for a portfolio of over 20,000 units in many states plus the District of Columbia.  Edgewood’s portfolio represents a variety of multifamily...

  • Assistant Community Manager- Affordable Housing

    7 days ago

    Wilmington, United States Edgewood Management Corporation Full time

    Job DescriptionJob DescriptionAssistant Community ManagerEdgewood Management Corporation is a 50+ year old premiere affordable property management company, providing superior real estate and property management for a portfolio of over 20,000 units in many states plus the District of Columbia.  Edgewood’s portfolio represents a variety of multifamily...

  • Plumbing Material Specialist

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Wilmington, United States Sobieski Full time

    Job Description Job Description PLUMBING MATERIAL SPECIALIST - NEW HOME CONSTRUCTION DIVISION Sobieski New Homes of Newark, DE is looking to hire a full-time PLUMBING Material Specialist. Are you interested in a career with a growing company and supportive team ? The Material Specialist earns a competitive salary depending on experience. We also offer...

  • Plumbing Material Specialist

    Found in: Lensa US P 2 C2 - 7 days ago

    Wilmington, United States CareerBuilder Full time

    Job Description Job Description PLUMBING MATERIAL SPECIALIST - NEW HOME CONSTRUCTION DIVISION Sobieski New Homes of Newark, DE is looking to hire a full-time PLUMBING Material Specialist. Are you interested in a career with a growing company and supportive team ? The Material Specialist earns a competitive salary depending on experience. We also offer...

  • Plumbing Material Specialist

    2 weeks ago

    Wilmington, United States Sobieski Full time

    Job DescriptionJob DescriptionPLUMBING MATERIAL SPECIALIST - NEW HOME CONSTRUCTION DIVISIONSobieski New Homes of Newark, DE is looking to hire a full-time PLUMBING Material Specialist. Are you interested in a career with a growing company and supportive team? The Material Specialist earns a competitive salary depending on experience. We also offer excellent...

  • Health Information Management Specialist/Medical Records

    Found in: Lensa US P 2 C2 - 7 days ago

    Wilmington, United States CareerBuilder Full time

    Job Type Full-time Description WESTSIDE IS LOOKING FOR MEDICAL RECORDS / HEALTH INFORMATION SPECIALISTS! JOIN A CARING, DEDICATED TEAM WHO HELPS PATIENTS AND FAMILIES GAIN ACCESS TO HEALTHCARE, AND NAVIGATE COMMUNITY SERVICES AND RESOURCES. Westside Family Healthcare is a nonprofit organization that provides high quality primary medical care without regard...

  • Health Information Management Specialist/Medical Records

    Found in: Lensa US P 2 C2 - 1 week ago

    Wilmington, United States Westside Family Healthcare Full time

    Job Type Full-time Description WESTSIDE IS LOOKING FOR MEDICAL RECORDS / HEALTH INFORMATION SPECIALISTS!JOIN A CARING, DEDICATED TEAM WHO HELPS PATIENTS AND FAMILIES GAIN ACCESS TO HEALTHCARE, AND NAVIGATE COMMUNITY SERVICES AND RESOURCES. Westside Family Healthcare is a nonprofit organization that provides high quality primary medical care without regard to...

  • Senior Quality Specialist

    Found in: beBee jobs US - 2 weeks ago

    Wilmington, Delaware, United States Proclinical Staffing Full time

    Senior Quality Specialist - Wilmington, DE - ContractProclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing. This is a contract position located in Wilmington, DE.Primary Responsibilities:The successful candidate will ensure the appropriate use and improvements of...

  • Youth Rehabilitation Treatment Specialist

    29 minutes ago

    Wilmington, United States State of Delaware Full time

    This is the full performance level of work providing case management services to youth in residential settings. Work includes coordinating the youth’s treatment plan and monitoring progress and achievement of goals to prepare youth for release and transition back to their home, community and school. Positions at this level typically report to a technical...

  • SBTDC International Business Development Specialist

    6 days ago

    Wilmington, United States University of North Carolina Wilmington Full time

    The SBTDC International Business Development Specialists responsibilities include: Global Business Management: evaluate export readiness for new to export clients, and develop strategies and tactics for exporting Global Marketing: identify potentia Business Development, International, Specialist, Business, Development, Intern, Business Services

  • supervisory logistics management specialist

    Found in: beBee jobs US - 7 days ago

    Wilmington, Delaware, United States Department Of The Army Full time

    SummaryTHIS IS A NATIONAL GUARD TITLE 5 EXCEPTED SERVICE POSITION.This National Guard position is for a SUPERVISORY LOGISTICS MANAGEMENT SPECIALIST, Position Description Number T5118000 and is part of the DE United States Property and Fiscal Office, National Guard.Duties 1. Plans, organizes, and oversees the activities of the USPFO Logistics Division....

  • Children & Youth Program Specialist

    Found in: Talent US C2 - 2 weeks ago

    Wilmington, United States The Mary Campbell Center Full time

    The Mary Campbell Center is first, last, and always, home to 68 residents. Together, staff ensures services are delivered with a high degree of quality, in a homelike environment where residents live with respect, personal dignity, and independence to the fullness of their abilities. The C & Y Program Specialist assists the C&Y Program Manager and C&Y Plus...