<p>An experienced Clinical Data Manager will oversee the management and integrity of clinical trial data from capture through database lock. The role requires strong technical skills, attention to detail and excellent communication with clinical, biostatistics and regulatory teams. The successful candidate will ensure data quality, regulatory compliance and timely delivery of datasets for analysis.</p>
<p>This job description outlines the responsibilities, required skills and qualifications for hiring a Clinical Data Manager. It is designed to help HR, recruiters and staffing agencies attract and assess top candidates for clinical data roles.</p>
<h2>Clinical Data Manager Job Profile</h2>
<p>The Clinical Data Manager plans and supervises data collection, cleaning and validation activities for clinical studies. They design data management plans and ensure adherence to industry standards and regulatory requirements.</p>
<p>The role liaises with clinical operations, biostatistics and vendors to maintain database integrity and support timely submission of trial data. Familiarity with EDC systems and data standards is essential.</p>
<h2>Clinical Data Manager Job Description</h2>
<p>A Clinical Data Manager is responsible for the end to end management of clinical trial data. This includes designing case report forms, configuring electronic data capture systems, developing data management plans and implementing validation checks. The manager ensures that data are accurate, complete and consistent with the trial protocol and source documents.</p>
<p>The role involves close collaboration with clinical project teams, statistical programmers and external vendors to resolve data queries, reconcile data discrepancies and prepare locked datasets for analysis. The Clinical Data Manager oversees data cleaning timelines, documents data handling activities and supports regulatory inspections as required.</p>
<p>Senior Clinical Data Managers may lead small teams, manage vendor contracts and drive process improvements in data management workflows. Strong understanding of CDISC standards, GCP and relevant regulatory guidance is expected. Excellent organisational skills and the ability to prioritise competing demands are essential to meet study milestones.</p>
<h2>Clinical Data Manager Duties and Responsibilities</h2>
<ul>
<li>Develop and maintain data management plans and study specific documentation.</li>
<li>Design and implement electronic case report forms and EDC system configuration.</li>
<li>Create data validation checks, edit checks and query management procedures.</li>
<li>Manage data cleaning activities and ensure timely resolution of data queries.</li>
<li>Perform database testing, data exports and reconciliation with clinical databases.</li>
<li>Prepare and deliver datasets in line with CDISC standards for statistical analysis.</li>
<li>Coordinate with clinical operations, biostatistics and safety teams to ensure data integrity.</li>
<li>Oversee vendor performance, including data entry and central laboratory data transfers.</li>
<li>Maintain audit trails and documentation to support regulatory inspections.</li>
<li>Train and mentor junior data management staff and provide technical guidance.</li>
</ul>
<h2>Clinical Data Manager Requirements and Qualifications</h2>
<ul>
<li>Bachelor's degree in life sciences, computer science, statistics or related field; master’s preferred.</li>
<li>Proven experience in clinical data management within pharmaceutical or CRO settings.</li>
<li>Hands on experience with EDC systems such as Medidata Rave, Oracle Clinical or equivalent.</li>
<li>Strong knowledge of GCP, CDISC standards including SDTM and ADaM, and regulatory requirements.</li>
<li>Proficiency in SQL, data validation and data cleaning techniques.</li>
<li>Excellent written and verbal communication skills and attention to detail.</li>
<li>Ability to lead cross functional teams and manage multiple studies concurrently.</li>
<li>Experience with query management tools, medical coding and data reconciliation is desirable.</li>
</ul>