Qureos Mentor

Katalyst Healthcares & Life Sciences

<div><div><b>Responsibilities:</b>
<ul><li>Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports.
</li><li>Manage high complex studies and support specific activities of studies managed by other data managers or consultants
</li><li>Provide technical tutoring and supervise data managers and/or contractors assigned to clinical studies by conducting regular reviews of activity status
</li><li>In-depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml)
</li><li>Manage and guide providers, setting requirements, preparing or reviewing Request for Proposals and monitoring performance.
</li><li>Regularly monitor data management costs of the assigned studies ensuring respect of budget.
</li><li>Define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results
</li><li>Ensure all data collection systems for assigned projects are setup, tested and fit for purpose according to expectations and timelines
</li><li>Define the strategy and lead the preparation of data package for regulatory submission
</li><li>Represent data management for auditing and regulatory inspection
</li><li>EHR data, data collected directly from patients, omics data, other secondary data)
</li><li>Advanced analytical and technical skills to interrogate and mine high volumes of data from a variety of sources.
</li></ul><b>Requirements:</b>
<ul><li>Minimum 8+ years of experience in Clinical Data Management in CROs or Pharmaceutical Industry
</li><li>Solid knowledge of drug development processes
</li><li>Strong data management expertise
</li><li>Excellent knowledge of Good Clinical Data practices, GCP and regulatory requirements
</li><li>Experience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors to collect data directly from patients
</li><li>Excellent knowledge of Risk-Based approach
</li><li>Knowledge of Real-World data sources and processes to collect/manage different types of sources.
</li><li>Basic knowledge of Artificial Intelligence (AI)
</li><li>Project Management skills
</li><li>Excellence in planning and priorities setting
</li><li>Analytical, problem-solving skills and ability to take ownership of decision-making
</li><li>Strong commitment to quality
</li><li>Excellent oral and written communication and presentation skills
</li><li>Ability to collaborate and work in a team-based environment
</li><li>Courage, resilience, and ability to adjust to a rapidly changing environment
</li><li>Experience with Medidata platform
</li><li>Familiarity with other platforms for secondary data
</li><li>Proficiency in SAS Systems.</li></ul></div></div>

Lead Clinical Data Manager

<div><b>Summary:</b>
<br>
We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.
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<b>Roles &amp; Responsibilities</b><b>
</b><ul><li>Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
</li><li>Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
</li><li>Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
</li><li>Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
</li><li>Oversee validation readiness and ensure prerequisites are met prior to formal testing
</li><li>Support change control, configuration management, and release activities
</li><li>Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
</li><li>Provide guidance on CSA-based, risk-driven validation approaches</li>
</ul><b>Education &amp; Experience :</b><b>
</b><ul><li>5&ndash;8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
</li><li>Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
</li><li>Strong understanding of CSA principles, CSV, and SDLC processes
</li><li>Experience authoring and/or reviewing validation documentation
</li><li>Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
</li><li>Ability to work independently in a fast-paced, matrixed environment
</li><li>Strong communication skills and comfort interacting with Quality and business stakeholders
</li><li>Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
</li><li>Prior role as a Validation SME, CSA Lead, or Compliance Consultan
</li><li>Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms</li></ul></div>

Computer System Assurance (CSA) Consultant

Join Katalyst Healthcares & Life Sciences and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Katalyst Healthcares & Life Sciences

ABOUT_COMPANY

Lead Clinical Data Manager

Computer System Assurance (CSA) Consultant