Clinical Data Manager jobs in Trenton, NJ

Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

T
Principal Clinical Data Manager
  • TK-CHAIN LLC
  • Princeton, NJ FULL_TIME
  • Notes: Candidate needs to be an individual or an independent contributor. Candidates from a complete CRO and FSP background are eligible.

    The Senior Clinical Data Manager (CDM) leads and coordinates Data Management (DM) deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.  This position also serves to contribute to process improvements, staff learning & development and provides input for DM services cost proposal.  The Senior CDM is a member of the Data Management staff. 

    Responsibilities: 

    ·         Serve as primary contact for DM with all relevant parties both internally (e.g., Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites) on a regular basis throughout the study 
    ·         Participate in the review of study documents (e.g., protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan) 
    ·         Provide support on clinical study database set-up, including eCRF design and database validation requirements. 
    ·         Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. 
    ·         Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks. 
    ·         Create training materials for EDC users and provide project-specific training as required. 
    ·         Review and validate clinical data to ensure consistency, accuracy, integrity and completeness. 
    ·         Create Data Cleaning Plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)  
    ·         Provide project metric reports, status updates, study progress, feedback, and advice to project team on site performance issues, data trends and protocol non-compliance etc. 
    ·         Perform and/or coordinate various data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. 
    ·         Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures 
    ·         Participate in conference calls and/or meetings with vendors and sponsors. 
    ·         Keep track on project timelines and manage changes of scope, budgets and resourcing needs. 
    ·         Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan 
    ·         Manage the database implementation, lock and close-out processes and procedures. 
    ·         Organize and distribute study data to facilitate statistical analysis and reporting. 
    ·         Maintain documentation on an ongoing basis and ensure that all filing is up to date. 
    ·         Plan and create necessary documentation to support internal and external audits; participates in such audits 
    ·         Provide leadership, guidance and support to other department members. 
     
    Qualifications: 

    ·         B.S. degree in life science, healthcare and/or related field 
    ·         Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements 
    ·         Experience with tools and systems for managing clinical studies.  
    ·         Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)  
    ·         Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models. 
    ·         Eye for detail, strong technical, analytical and problem-solving skills 
    ·         Ability to simplify complex issues into understandable concepts. 
  • Just Posted

P
Sr. Clinical Data Manager
  • pmvpharma
  • Princeton, NJ FULL_TIME
  • Sr. Clinical Data Manager, Clinical DevelopmentPMV Pharma is developing first-in-class p53 regulators for the treatment of cancer. Bringing together leaders in the field to utilize over three decades ...
  • 13 Days Ago

A
DATA MANAGER WITH CLINICAL SAFETY
  • Artech LLC
  • Lawrenceville, NJ FULL_TIME
  • CLINICAL SAFETY ANALYTICS / DATA MODELING / VISUALIZATION LAWRENCEVILLE, NJ 100% onsite The pay for this position ranges from $65.00 to $67.19 per hour. Project Description: Clinical Safety Analytics ...
  • 26 Days Ago

D
Information Technology Services Sales Manager – New York Government
  • Data-Core System, Inc.
  • Bristol, PA OTHER
  • Information Technology Services Sales Manager – Government Data-Core is currently in search of an experienced Information Technology Sales Manager – Government. This role is integral to propelling the...
  • 4 Days Ago

S
Call Center Quality Manager
  • Syneos Health Clinical
  • Princeton, NJ FULL_TIME
  • Description You’re driven, resourceful, and above all else - remarkably smart. You are the first to roll up your sleeves and work with endless energy until you solve the unsolvable, beat the unbeatabl...
  • Just Posted

S
Call Center Quality Manager
  • Syneos Health Clinical
  • Newtown, PA FULL_TIME
  • Description You’re driven, resourceful, and above all else - remarkably smart. You are the first to roll up your sleeves and work with endless energy until you solve the unsolvable, beat the unbeatabl...
  • Just Posted

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Clinical Data Manager jobs found in Trenton, NJ area

A
Head of Business - Practice & FSP Operations- Life sciences
  • ACL Digital
  • King of Prussia, PA
  • Responsible for setting up, directing, and executing the life sciences roadmap for the organization. Have the complete r...
  • 3/28/2024 12:00:00 AM

P
Travel Nurse RN - Dialysis - $2,448 per week
  • PRN Healthcare
  • Trenton, NJ
  • Hired by Matrix is seeking a travel nurse RN Dialysis for a travel nursing job in Trenton, New Jersey. Job Description &...
  • 3/28/2024 12:00:00 AM

M
Senior Computer Systems Validation Analyst
  • Maxis Clinical Sciences
  • Edison, NJ
  • Job Description Job Description Review of URS document and understand the functionality Responsible for all the validati...
  • 3/27/2024 12:00:00 AM

G
Senior Clinical Data Manager (Hybrid)
  • Genmab A/S
  • Princeton, NJ
  • At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneeri...
  • 3/27/2024 12:00:00 AM

G
Contractor - Senior Clinical Data Manager (Hybrid or Remote)
  • Genmab A/S
  • Princeton, NJ
  • At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneeri...
  • 3/27/2024 12:00:00 AM

T
Business Development Manager, Life Sciences, Clinical Platform
  • Tephra
  • Edison, NJ
  • Description: Job Title: Business Development Manager Life Sciences Clinical Platforms, NA Location: New Jersey, USA Job ...
  • 3/27/2024 12:00:00 AM

P
Associate Director, Clinical Biomarker Lead
  • PMV Pharmaceuticals, Inc.
  • Princeton, NJ
  • Title/Position: Associate Director, Clinical Biomarker Lead Reports to: Head of Clinical Pharmacology and Pharmacometric...
  • 3/26/2024 12:00:00 AM

S
Dental Hygienist
  • Shady Brook Family Dental
  • Morrisville, PA
  • Shady Brook Family Dental for a part-time Licensed hygienist to join our team! Flexible schedule & Competitive Pay. We p...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the city had a total area of 8.155 square miles (21.122 km2), including 7.648 square miles (19.809 km2) of land and 0.507 square mile (1.313 km2) of water (6.21%). Several bridges across the Delaware River – the Trenton–Morrisville Toll Bridge, Lower Trenton Bridge and Calhoun Street Bridge – connect Trenton to Morrisville, Pennsylvania, all of which are operated by the Delaware River Joint Toll Bridge Commission. Trenton is located near the exact geographic center of the state, which is 5 miles (8.0 km) located southeast of Trenton. The city is so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Data Manager jobs
$122,272 to $152,229
Trenton, New Jersey area prices
were up 1.5% from a year ago

Clinical Data Manager in Milwaukee, WI
Clinical data managers are highly responsible for the success of clinical trials.
December 18, 2019
Clinical Data Manager in Denver, CO
Statisticians design surveys, questionnaires, experiments, and opinion polls to collect the data they need.
January 03, 2020
Clinical Data Manager in Danbury, CT
The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities.
January 03, 2020