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Actalent Biomarker Clinical Data Manager (Lab Data Manager) in Cambridge, Massachusetts

Title: Senior Manager, Clinical & Biomarker Data Management

Location: Cambridge, MA

Reports to: Senior Director, Clinical Data Management

The Role:

The Senior Manager, Clinical & Biomarker Data Management, reporting to the Senior Director, Clinical Data Management, is uniquely situated to support the

Clinical Data Management team as well as the Clinical Biomarker team. 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.

Here’s What You’ll Do:

· 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 effort

Here’s What You’ll Bring to the Table:

  • 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/audits

    About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.