Manager Medical Data Review*

at  Immatics Biotechnologies GmbH

72076 Tübingen, Baden-Württemberg, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate27 Nov, 2024Not Specified31 Aug, 2024N/AGood communication skillsNoNo
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Description:

OVERVIEW

We are currently seeking a Manager Medical Data Review* to strengthen our Clinical Development team. You will be based in Tübingen or Munich (Germany) and collaborate within an interdisciplinary environment with colleagues from Germany and the US (Houston, TX). Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.

ABOUT US

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For more detailed information, visit www.immatics.com.

Responsibilities:

  • Authoring SOPs and Plans for Medical Data Review, ensuring alignment with other project plans and Immatics’ SOPs and procedures.
  • Compiling the Medical Review Checklist in collaboration with the Physician (Medical Monitor) and Data Management.
  • Generating Data Review Extracts from the EDC system and/ or Data Review outputs from JReview; working closely with Data Management colleagues to develop and review Standard and Customized Data.
  • Reviewing outputs to ensure consistency with other project plans and Immatics’ SOPs and procedures.
  • Reviewing medical data for consistency and plausibility, ensuring the data is comprehensive from a medical perspective across different studies and projects.
  • Performing Query Management (raising and responding to medical queries, consulting with the Physician as needed, and having a general understanding of the protocol and other relevant study documents such as the Data Management Plan, CRF, CRF Completion Guidelines, and Edit Check Specifications).
  • Generating Medical Data Review Summaries, including an overview of findings.
  • Reviewing and addressing QC findings as required.
  • Attending Investigator Meetings for large projects, as necessary.
  • Demonstrating proficiency in various EDC systems and being able to train other clinical team members.
  • Collaborating closely with various members of the Data Management team (internal and external vendors/ contractors).
  • Performing other tasks as directed by the Physician or Clinical Sciences personnel, such as Vendor Management, and supporting Medical Monitoring


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

72076 Tübingen, Germany