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Clinical Data Management Associate

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Clinical Data Management Associate provides data management support for FMI’s biopharmaceutical and academic research partners as data is generated, analyzed, and monitored. The role is responsible for standard data deliverables, such as standard genomic analysis, and serves as a point of contact between FMI's cross-functional teams and external biopharma and academic partners’ study teams.

Key Responsibilities

•        Responsible for standard data deliverables such as standard genomic analysis to biopharmaceutical and academic research partners.

•        Provide support for the execution of raw data requests and non-standard data requests.

•        Provide support for review and quality control activities for formal data transfers to external partners, including IXRS (interactive response system) transfers and data reconciliation.

•        Provide support for ongoing studies to the data management team to meet data deliverable requirements.

•        Provide support for internal process improvements around data delivery.

•        Provide input to the internal software development team to improve processes and technology used to perform data transfers and assist in reconciliation efforts.

•        Act as point of contact for internal collaborations with Clinical Operations, Information Technology, and special project teams.

•        Participate in Standard Operating Procedure (SOP) development and revision.

•        Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a health or science field

Preferred Qualifications

• 1+ years of academic or professional experience in clinical oncology trials and/or handling complex clinical data sets including genomic data

• 1+ years of work experience in the science or health industry

• Experience in a Clinical Research Organization (CRO) or lab vendor environment

• Experience in scientific data management in various phases of project design and analysis

• Track record of applying attention to detail and of meeting short- and long-term deadlines

• Knowledge of and experience working within Good Clinical Practices, International Conference on Harmonization requirements, Clinical Data Interchange Standards Consortium standards and other guidelines pertinent to clinical data

• Demonstrated excellent communication and collaboration skillset including ability to diffuse difficult conversations

• Demonstrated ability to:

• Work well under pressure while maintaining a professional demeanor

• Prioritize and thoroughly follow up on assigned tasks

• Handle multiple tasks at once and work in a fast-paced environment

• Adapt to changing procedures, policies and work environment

• Learn new software and technologies

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI's values: Passion, Patients, Innovation, and Collaboration

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Internal applicants, please use your FMI email address.

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