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

VkV3VWhCdjFwMU5QZmU1dTBUMks3MWNjSkE9PQ==
  • 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

Scotiabank

Assistant Manager, Funding Operations - Mortgage Capital Markets Operations Job at Scotiabank

 ...results, in an inclusive and high-performing culture. Global Banking and Markets Global Banking and Markets (GBM) is a...  ..., integration with clients to the platform, coordinating with back office on account setup, cash management / treasury services - Work... 

Feld Entertainment, Inc.

Animation & Illustration Artist Job at Feld Entertainment, Inc.

Design and create 2D & 3D animation art for Monster Trucks, Helmets, Fire suits, and crew shirts. Illustrate sketching of initial concepts to implementation of computer-generated concept develop including 3D models, textures & skins. Utilizes 3D and 2D resources to expedite... 

Visiting Nurse Association of Southeast Missouri

Part-time Home Health LPN Job at Visiting Nurse Association of Southeast Missouri

INTRODUCTION: The Home Health program provides services for those needing skilled services under orders from a private physician delivered in the patient"s private home. Payment is through Medicaid, Medicare and Private Pay/Insurance. Visiting Nurse Association of Southeast... 

TEMO Sunrooms

Carpentry Crew Leader and a Masonry Crew Leader Job at TEMO Sunrooms

TEMO, Inc. is seeking a Carpentry Crew Leader and a Masonry Crew Leader, which is responsible for leading the installations of our product line. With more than 50 years of experience, TEMO, Inc. stands as the leading manufacturer of sunrooms, pergolas, patio covers, and... 

Pacific Shipyards International, LLC

Government Estimating Supervisor Job at Pacific Shipyards International, LLC

Position Title: Government Estimating Supervisor Reports To: Estimating Manager Position Summary : PSI is the largest privately...  ...of Engineering, Project Management, QA, EHS, Accounting, Contracts, Estimating, and Human Resources. Pacific Shipyards is searching...