Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. Our goal is to deliver adoptive cellular immunotherapies for novel cancer targets in indications with highly unmet medical need. Immatics is the leading biopharmaceutical company in the development of cancer immunotherapeutics based on tumor-associated peptides (TUMAPs) that constitute the most relevant targets for all T-cell based immunotherapies.
Immatics US pipeline is based on adoptive cellular therapy (ACT). ACT has demonstrated dramatic clinical effects in melanoma and certain blood cancers. However, relevant and safe targets to translate these initial successes to other cancer types are critically lacking to the field. ACT has the potential to induce significant clinical benefits including rapid clinical responses and can potentially be developed up to FDA marketing approval within few years.
Immatics US is headquartered in Houston with a significant R&D infrastructure. Immatics US has a team of highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science. We offer a competitive salary based on experience, and a comprehensive benefits package.
Clinical Document Control Specialist (Exempt)
The primary purpose of the Clinical Document Control Specialist is to provide support to clinical research, including but not limited to maintenance of essential documentation, clinical trial tracking and information retrieval. This position plays a crucial part and is considered a key contact before, during and after the clinical trial concludes. This position shall assist in the coordination and management of documentation associated with conducting clinical studies.
- Responsible for managing and maintaining the electronic Trial Master File (eTMF) which includes development and maintenance of an Expected Documents List (EDL), uploading study documentation, ongoing eTMF reconciliation, quality checking uploaded documents, working with the clinical staff to ensure the eTMF is complete and inspection ready and holding the study team accountable for missing documentation.
- Responsible for clinical documentation management and tracking, prioritizing tasks and ensuring adherence to timelines.
- Maintain the eTMF in an audit and archive status.
- Critically review document content to ensure accuracy and completeness prior to upload.
- Communicate discrepancies or inconsistencies.
- Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines, work instructions and appropriate industry Good Clinical Practice Standards.
- Other duties as assigned.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- Bachelor’s degree preferred.
- Three years of experience working in clinical research records management department or equivalent experience.
- Experience with eTMF and familiarity with eTMF processes and procedures. Experience with MasterControl eTMF is a plus.
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
- Advanced skills using MS Word, SharePoint, Adobe Acrobat Professional. Excel and PowerPoint skills are preferred.
Other Skills and Abilities
- Must be able to multitask, prioritize and work under pressure while adhering to deadlines.
- Possess strong oral and written communication and interpersonal skills.
- Strong project management and organizational skills.
- Very detail oriented.