Clinical Data Manager Job at cGxPServe, Dallas, TX

RlpkZ3BGY2tWV1hmSjBuQ1o4YlRCbXBz
  • cGxPServe
  • Dallas, TX

Job Description

Responsibilities:
  • Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
  • Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
  • Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
  • Develop and oversee maintenance all data management documentation for all clinical studies.
  • Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
  • Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
  • Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
  • Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
  • Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
  • Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
  • Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
  • Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
  • Develop, implement, and continuously improve clinical data management processes and systems.
  • Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.
Requirements:
  • Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
  • Strong understanding of data structure and data systems.
  • Minimum of 5+ years of experience in clinical data management.
  • Proven experience managing data across multiple phases of clinical trials
  • Proficiency with EDC systems (e.g., Medidata Rave, Medio).
  • Strong understanding of CDISC standards (CDASH, SDTM, Adam) as well as WHO Drug and MedDRA coding.
  • Familiarity with data reporting tools is a plus.
  • Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards.
  • Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
  • Excellent communication, problem-solving, and decision-making skills.
  • Certified Clinical Data Manager (CCDM) or similar certification is preferred.

Job Tags

Similar Jobs

NoGigiddy

Apply Now: Remote Customer Service Jobs with Pay at 19 Per Hour Job at NoGigiddy

Remote Customer Service Expert Starting at $19/hr, No Educational Requirements Do you pride yourself on your problem-solving skills and your ability to deliver exceptional customer service? Were expanding our team and looking for Remote Customer Service Experts who...

MMI Industrial & Steel

Safety Manager Job at MMI Industrial & Steel

 ...Position Summary: An MMI Industrial & Steel onsite safety manager is responsible for the daily safety overview of the site, this includes the direct management of onsite safety professionals performing activities designed to reduce the risk of accidents in the workplace... 

Milliken and Company

Occupational Health Nurse, Ovik Health Job at Milliken and Company

 ...inspired solutions at Milliken.com and on Facebook , Instagram , LinkedIn and Twitter . POSITION TITLE: Occupational Health Nurse, Ovik Health JOB LOCATION: Salisbury, MA POSITION REPORTS TO: Senior Director of Human Resources... 

Sedgwick

Workers Compensation Claims Adjuster | Rancho Cordova, CA (Hybrid 2 Days) Job at Sedgwick

 ...Top CompaniesCertified as a Great Place to WorkFortune Best Workplaces in Financial Services & InsuranceWorkers Compensation Claims Adjuster | Rancho Cordova, CA (Hybrid 2 Days)Are you looking for an opportunity to join a global industry leader where you can bring... 

JCSI

Plant Operator Job at JCSI

 ...Plant Operator Location : Millbury, MA Compensation : $56/hour + $10,000 Sign-On Bonus! Why Join Us? Take on a critical role with a leading organization at the forefront of waste management and renewable energy production. As a Plant Operator , youll play...