Invitae
Invitae

60 Invitae Clinical Data Manager Jobs Hiring Near You

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 ...

The Clinical Data Manager (CDM) handles project management documentation, clinical data management activities, and system implementations for EDETEK's eClinical, and may be assigned work on other ...

Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close * This includes the EDC build and user acceptance ...

The Clinical Data Manager will plan and oversee all data management activities across assigned studies relatedcompaniondiagnostics (CDx) development to ensuretimely,accurate, and compliant data ...

Clinical Data Manager

San Diego, CA ยท On-site

$110K - $120K/yr

The Clinical Data Manager will ensure timely conduct of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, Standard Operating ...

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 ...

Clinical Data Manager

Austin, TX ยท On-site

$125K - $175K/yr

Faeth Therapeutics is seeking an experienced Clinical Data Manager to support clinical data management activities across two active clinical trials. This individual will play a critical role in ...

Clinical Data Manager

Austin, TX ยท Remote

$125K - $175K/yr

Faeth Therapeutics is seeking an experienced Clinical Data Manager to support clinical data management activities across two active clinical trials. This individual will play a critical role in ...

Clinical Data Manager

Burlington, MA ยท On-site

$145K - $160K/yr

We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role ...

Clinical Data Manager

Austin, TX ยท Remote

$125K - $175K/yr

Faeth Therapeutics is seeking an experienced Clinical Data Manager to support clinical data management activities across two active clinical trials. This individual will play a critical role in ...

Clinical Data Manager City: Columbia, MD Country/Region: United States State: Business Area: Clinical Research Department: Clinical Affairs Employment Type: Full-time Req ID: 10220 Job Title:

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Invitae Jobs Information

What is it like to work at Invitae?

Invitae is a company that prioritizes collaboration, innovation, and a patient-centric approach to genetic testing and diagnostics. The company's structure is organized into multidisciplinary teams that work together to develop and improve genetic testing products, with a focus on creating a supportive and inclusive work environment. Working at Invitae may appeal to candidates who are passionate about advancing genetic medicine and are interested in contributing to a mission-driven organization that aims to improve human health.

What makes Invitae an attractive place to work?

Invitae is a leading genetic information company that aims to make high-quality genetic testing accessible to everyone, positioning itself at the forefront of the rapidly evolving genetic medicine industry. The company's workplace is characterized by a culture of innovation, collaboration, and teamwork, with opportunities for employees to contribute to cutting-edge research and development in genetics and genomics. By joining Invitae, individuals can leverage their skills and expertise to drive meaningful impact in the field of genetic medicine and enjoy opportunities for professional growth and development.

Clinical Data Manager

Katalyst Healthcares & Life Sciences

Jacksonville, FL โ€ข On-site

Other

Re-posted 22 days ago


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.
  • Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution.
  • 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, Medrio).
  • 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.
  • Ability to work collaboratively with cross-functional teams and manage
  • relationships with external vendors.
  • Certified Clinical Data Manager (CCDM) or similar certification is preferred.

Katalyst Healthcares & Life Sciences logo

About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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