Contract Clinical Data Manager New Bothell, Washington, United States

Immunome, Inc.; Bothell (WA); On-site; Part time

Job summary

An innovative firm is on the lookout for a Clinical Data Manager to join their team on a part-time basis. This role is crucial in ensuring the quality and integrity of clinical data for ongoing studies. The ideal candidate will have a solid background in clinical data management and a keen eye for detail. You will collaborate with various teams to streamline data processes and ensure compliance with regulatory standards. If you are passionate about improving patient outcomes and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 3+ years of clinical data management experience in pharma or biotech.
• Proficient in EDC systems and CDISC standards.

Responsibilities

• Manage end-to-end clinical data processes for studies.
• Collaborate with teams to define data collection needs.

Skills

Clinical Data Management

Attention to Detail

Problem-Solving

Communication Skills

Education

Bachelor’s degree in Life Sciences

Bachelor’s degree in Computer Science

Tools

Medidata Rave

Oracle Clinical

Job description

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

Immunome, Inc. is seeking an experienced Clinical Data Manager for a part-time, 6-month contract position to support our clinical data operations. The ideal candidate will play a pivotal role in ensuring the quality, integrity, and timely management of clinical data for ongoing and upcoming studies.

Responsibilities

• Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
• Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
• Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
• Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
• Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
• Perform quality control and audit activities to ensure data accuracy and compliance.
• Support data reviews and provide metrics and status updates to project teams and leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or a related field.
• Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.

Knowledge and Skills

• Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
• Exceptional attention to detail and problem-solving skills.
• Ability to work independently and communicate effectively with diverse stakeholders.

Washington State Pay Range

$55 - $70 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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