Clinical Data Manager – Clinical Operations

We are currently seeking a Full Time

Clinical Data Manager

for our CLINICAL OPERATIONS DEPARTMENT to support our Team.

Job Overview

This position will work in Houston, Texas. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.

Overall Responsibilities

The main responsibilities of this position will include but are not limited to the following tasks:

  • Lead data management activities and ensure study deliverables meet timelines and quality standards.
  • Work with complex computerized records systems and maintain security and integrity.
  • Collect data from clinical trials.
  • Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
  • Query data inconsistencies and revise case report forms in compliance with SOP.
  • Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis and final database lock.
  • Implement strategy for data cleaning and design and programming of clinical databases.
  • Review of clinical research documents (e.g. Protocols, Case Report Forms).
  • Create and review electronic Case Report Form (eCRF) specs.
  • Develop critical data management documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
  • Coordinate the archiving of study databases and related documents.
  • Support clinical data analyses and reporting for regulatory submission and scientific publications as member of a cross-functional team.
  • Perform SAE Reconciliation.

Qualification

The qualifications for this position include, but are not limited to the following:

  • REQUIRED: Bachelor’s Degree in Clinical or Science related field.
  • Three (3) years of experience in a medical device or pharmaceutical industry preferred.
  • Working knowledge of Clinical research and Clinical trial process and related regulatory requirements and terminology.
  • Strong knowledge and experience in several Electronic Data Capture (EDC) systems.
  • Demonstrated understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as related pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
  • Ability to prioritize and adapt quickly in a fast-paced and changing industry.
  • Proactively drive quality and efficiency to meet timelines and milestones to deliver high quality data management deliverables.
  • Excellent verbal and written communication skills.

We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.

What Immatics offers

We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. Immatics offers partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.

If you’re interested in working for Immatics, please forward you CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.