Clinical Data Manager Job at Custom Search Inc., Maple Grove, MN

S1hURHkwUm1iTmRvblo2SVlQa0lXeHpDN0E9PQ==
  • Custom Search Inc.
  • Maple Grove, MN

Job Description

Our small start-up client is adding a scientific minded Clinical Data Manager to join their team. In this role, you will oversee the data management aspects of clinical trials from beginning to end. Your main focus will be on ensuring data integrity, quality, and compliance with clinical trial requirements. This position requires a strong understanding of cardiovascular knowledge, proficiency in clinical data management processes, excellent project management skills, and the ability to collaborate effectively with cross-functional teams. If you have database/programming experience, you will have the opportunity to do both. They have a consultant who designed feasibility, and this person will manage the pivotal trial.

Your role with the company:

  • Maintain and update data management documentation (e.g., data management plans, data reports, etc.).
  • Perform data review and query management to ensure completeness, accuracy, and consistency of clinical trial data.
  • Create recruitment statistics for clinical field staff to review with the study sites to ensure efficient recruitment.
  • Regularly review protocol deviation reports to ensure trial compliance.
  • Regularly review adverse events summary with clinical project manager and safety manager.
  • Manage clinical trial database (Catchtrial), including data entry, cleaning, and lock activities.
  • Coordinate with study teams, clinical sites, and other stakeholders to resolve data issues and ensure timely database lock.
  • Ensure compliance with relevant regulatory requirements and industry standards (e.g., FDA guidelines, ICH-GCP).
  • Contribute to the development and implementation of standard operating procedures (SOPs) for data management activities.
  • Provide training and support to internal and external stakeholders on data management processes and systems.
  • Stay aware of any noteworthy data trends.

Desired Profile:

  • Bachelor’s degree in life sciences, computer science, or a related field.
  • Minimum of 3-5 years of experience in clinical data management within the medical device industry. Experience with structural heart ideal.
  • Strong knowledge of clinical trial processes and regulations (FDA, ICH-GCP).
  • Excellent organizational, communication, and problem-solving skills.
  • Ability to work effectively in a team environment and manage multiple priorities.
  • Experience with EDC systems and electronic submission standards is preferred.
  • Ability to interpret complex data and present it in a clear and understandable manner.

Job Tags

Remote job,

Similar Jobs

Everest Clinical Research

Remote Senior Clinical Data Manager Job at Everest Clinical Research

 ...re Growing in Poland! Everest Clinical Research is a global Clinical...  .... If youre driven by data, eager to make a meaningful impact...  ...part of a Statistical and Data Management Center of Excellence, we...  ...reporting. # Assist with study-level resource planning and... 

Vector Media

Bus Ad Installer Job at Vector Media

 ...impression. In an advertising world cluttered with screens and scrolls, we deliver real-world media with real results. From digital bus shelters and street-level storytelling to experiential activations, college campus and sports partnerships, we connect brands with... 

Swanton Welding Company

MIG welder Fabricator Job at Swanton Welding Company

 ...to excellence and innovation. We are seeking a skilled Robotic Welder Operator to join our team in Griffin, GA. This role involves operating...  ...and program robotic welding equipment efficiently. Perform MIG welding and manual welding during robot cycles as needed.... 

USAA

Senior Model Validator Job at USAA

 ...years of relevant experience beyond the minimum may substitute for a degree. You should have a minimum of six years of experience in model validation, model development, statistical analysis, or advanced quantitative research. If you possess an advanced degree (e.g.,... 

MKEC Engineering

Landscape Architect Job at MKEC Engineering

 ...our growth has been fueled by respect for each other and a shared commitment to achieving our goals. We're looking for a Landscape Architect to join our Landscape Architecture and Land Development team at our Overland Parklocation (in office). This individual will...