Biomarker Clinical Data Manager

Overview - Clinical Data Manager (Biomarker)This role will manage the sample reconciliation and well as data flow and transfers for the entire portfolio of clinical biomarker data, to ensure timely and quality data collection and data reporting throughout the clinical trial lifecycle.Responsibilities Collaborate with study teams to oversee CRO/service providers for all clinical biomarker data needs Seek means of improving processes to reduce cycle time, increase accuracy and decrease work effort Manage processes and timelines for clinical biomarker sample reconciliation efforts by CRO to ensure data is cleaned in a timely manner Perform oversight/data review on all clinical biomarker data transfers for Data Management and Clinical Biomarker team Receive, review quality, and organize clinical biomarker data, incorporating information into internal/external databases as needed Coordinate data transfers and data transfer agreements with clinical biomarker team and assay labs as needed Develop and update data transfer specifications through collaboration with clinical biomarker team to ensure consistent data transfers Coordinate data requirements with assay labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specifications Author, manage and track all Data Transfer Specifications for DM and CB Create, execute and/or distribute clinical biomarker data management metrics, listings and reports as required Support development and/or implementation of systems or technologies to support optimizing data flow or data status reporting Improve processes to reduce cycle time, increase accuracy and decrease work effortQualifications/Experience: BS degree in Life Science, math, computer science or other related field required 5+ years of clinical development or relevant drug development experience Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH) Laboratory background and/or working knowledge of commonly tested biomarkers across a variety of different therapeutic areas including infectious disease and oncology setting, with latest and advanced analytics tool and assay experience preferred Previous LMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process. Prior experience with data transfers or management for diagnostic Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy. Vendor management and oversight experience Outstanding verbal and written communication skills, in addition to excellent organizational skills Creative, capable problem-solver Experience in regulatory GCP inspections/auditsDiversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.About Actalent Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.