Clinical Data Manager

Job title: Clinical Data Manager

Location: Canda, UK, Eastern Europe, LATAM

Job Summary

The Clinical Data Manager (CDM) is responsible for performing clinical data management activities supporting Phase I–III clinical trials in accordance with ICH, Good Clinical Practice (GCP), applicable regulatory requirements, and organizational standard operating procedures (SOPs).

The Clinical Data Manager serves as the primary data management representative for assigned clinical studies and is responsible for ensuring that data management activities are delivered on time, within budget, and to the highest achievable standards of quality. The CDM collaborates closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Clinical Database Programming, and other cross-functional teams to ensure the integrity, completeness, consistency, and reliability of clinical trial data.

Essential Functions and Responsibilities

• Serve as the primary Clinical Data Management representative on assigned client and cross-functional study teams, ensuring effective communication, collaboration, and timely resolution of data management issues.
• Plan, coordinate, and execute clinical data management activities throughout the study lifecycle, from study start-up through database lock and archival.
• Communicate key clinical data management metrics and study status updates, including data entry status, query generation and resolution, query aging, data cleaning status, and other relevant performance indicators.
• Identify potential data management risks, trends, and issues and work collaboratively with the study team to determine appropriate corrective and preventive actions.
• Review, develop, and/or author clinical data management documents and study-specific manuals, including, but not limited to:
• Case Report Forms (CRFs/eCRFs)
• Data Management Plans (DMPs)
• Clinical Data Review Plans (CDRPs)
• Edit Check Specifications
• eCRF Completion Guidelines
• Data Validation Specifications
• Data Transfer Specifications
• Data Flow Diagrams/Charts
• Import/Export Guidelines
• Data Cleaning and Database Lock Plans
• Collaborate with Clinical Database Programmers to support the design, development, testing, and implementation of clinical databases, edit checks, data validation processes, and data integrations.
• Participate in User Acceptance Testing (UAT) and review testing results to ensure that the clinical database, edit checks, and related functionality meet study requirements.
• Participate in Quality Control (QC) activities, including review of data management deliverables, database functionality, study documentation, and data cleaning activities, as required.
• Perform ongoing clinical data review to identify missing, inconsistent, incomplete, or potentially erroneous data and ensure timely resolution of discrepancies.
• Review and manage data queries, monitor query resolution and aging, and provide guidance to study teams and sites to facilitate timely data cleaning.
• Support reconciliation of clinical data with external or third-party data sources, as applicable, including laboratory, imaging, central vendor, pharmacokinetic, ECG, eCOA, and other relevant data.
• Work closely with Clinical Operations and study sites to support timely data entry, discrepancy resolution, data cleaning, and overall database quality.
• Assist with site and/or third-party vendor training on Clinical Data Management processes, systems, data entry requirements, and study-specific procedures.
• Provide data review training, mentoring, and guidance to Senior Clinical Data Coordinators and other data management team members supporting assigned studies.
• Monitor study data quality and completeness throughout the study and escalate significant or recurring data issues to the appropriate study team members.
• Support the development and maintenance of study-specific data review strategies and ensure that data review activities are performed consistently and documented appropriately.
• Participate in study team meetings and provide data management updates, including study progress, risks, issues, milestones, and required action items.
• Contribute to study planning, timelines, resource estimates, and data management deliverables to ensure activities are completed within agreed timelines and budget.
• Support database freeze, interim database lock, and final database lock activities, including completion of data cleaning, query resolution, reconciliation, and required documentation.
• Ensure that all data management activities and study documentation are maintained in accordance with applicable SOPs, work instructions, study protocols, and regulatory requirements.
• Maintain appropriate study documentation and ensure that data management records are complete, accurate, current, and audit/inspection ready.
• Support internal and external audits and regulatory inspections by providing appropriate data management documentation and responding to data management-related findings or requests.
• Identify opportunities for process improvement and contribute to the development and implementation of standardized data management practices and efficiencies.
• Perform data review, discrepancy resolution, and other study-specific data management activities as required.
• Coordinate with internal teams and external vendors, as applicable, to ensure timely delivery and reconciliation of data and study-related deliverables.
• Support the identification, documentation, and resolution of data management deviations and issues, escalating significant concerns in accordance with applicable procedures.
• Responsible for the timely closeout and archival of assigned clinical trials and associated data management documentation upon study completion.
• Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, applicable local and international regulations, company SOPs, and client-specific requirements throughout the study lifecycle.

Minimum Qualifications and Requirements

• Minimum of 5 years of clinical data management experience , preferably supporting Phase I–III clinical trials.
• Bachelor’s degree in Life Sciences, Health Sciences, Clinical Research, Pharmacy, Nursing, or a related discipline is preferred. Certification in an allied health profession from an appropriately accredited institution (e.g., RN, MT, PA, RT) will also be considered.
• Equivalent relevant clinical research or clinical data management experience may be considered in lieu of the educational requirements.
• Demonstrated experience working with  Electronic Data Capture (EDC)systems is required.
• Experience with  Oracle InForm™ EDC is preferred.
• Strong understanding of clinical data management processes, database development, data cleaning, query management, data reconciliation, and database lock procedures.
• Working knowledge of  ICH/GCP guidelines , applicable regulatory requirements, and clinical research standards.
• Experience supporting  oncology and/or inflammatory therapeutic areas is preferred.
• Experience with clinical data review, edit checks, data validation, and external data reconciliation is preferred.
• Experience with third-party data/vendor management is preferred.
• Clinical Data Management project management experience is preferred.
• Previous experience working within a  Clinical Research Organization (CRO)or managing data management activities in a CRO environment is preferred.
• Experience working in a cross-functional, client-facing, or FSP environment is highly desirable.
• Strong analytical, organizational, problem-solving, and communication skills.
• Ability to manage multiple priorities, study deliverables, and timelines in a fast-paced clinical research environment.
• Ability to work independently while effectively collaborating with global, cross-functional teams.
• Strong attention to detail and commitment to data quality, integrity, and compliance.

Preferred Technical and Professional Skills

• Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint.
• Experience with clinical database and data management technologies and associated study documentation.
• Familiarity with clinical data standards and industry practices, including CDISC standards, is preferred.
• Ability to analyze clinical data trends and identify potential data quality concerns.
• Strong written and verbal communication skills, with the ability to communicate effectively with internal teams, clients, sites, vendors, and other stakeholders.
• Demonstrated ability to effectively prioritize tasks, manage competing deadlines, and proactively communicate risks and potential delays.