Senior Clinical Data Manager

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Oversee all components of the clinical trial data management process from the initiation of the study to post-database lock for designated projects.

• Adhere to SOPs/WIs, regulatory requirements, study-specific guidelines, and directives.

• Act as the main Data Management liaison or Lead DM for assigned clinical initiatives/programs.

• Supervise project data entry, including guidelines, training, quality assurance, and resource allocation.

• Evaluate and manage timelines, deadlines, and resource requirements.

• Create CRF specifications and facilitate stakeholder review when necessary.

• Conduct User Acceptance Testing (UAT) for database builds and maintain controlled database documentation.

• Ensure the quality of clinical databases and edit-check specifications.

• Develop, update, version, and maintain data management documentation as well as Trial Master File documentation.

• Provide training for clinical research personnel and data management project team members.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Execute line-listing data reviews and patient/study-level status and metric reporting.

• Carry out medical coding and coordinate the reconciliation of SAE/AE.

• Communicate with external data and EDC vendors concerning timelines and data-related deliverables.

• Assist with SAS programming and ensure quality control of SAS programs as required.

• Identify and resolve operational issues using metrics, audit reports, and feedback from stakeholders.

• Review and provide input on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) when necessary.

• Engage in the development and maintenance of SOPs and process documentation.

• Support strategy meetings, bid defenses, capability presentations, client engagement sessions, RFP evaluations, proposals, and project estimations.

• Provide leadership for cross-functional and organization-wide projects.

• Communicate with sponsors, vendors, and project teams regarding project-related matters.

• Deliver software demonstrations, training sessions, and conduct project meetings.

• Carry out other assigned responsibilities.

⛳️ Requirements

• Bachelor's degree or a combination of relevant experience.

• Minimum of 8 years’ experience as a Senior Clinical Data Manager or at least 5 years as a Clinical Data Manager II within a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience with setup and migration of databases.

• Oncology experience is preferred.

• Proficient in Microsoft Office: Word, Excel, PowerPoint, Outlook.

• Professional proficiency in the English language, both written and spoken.

• Familiarity with various clinical database management systems.

• Comprehensive understanding of drug, device, and/or biologic development along with effective data management practices.

• Strong skills in representation, organization, communication, leadership, and interpersonal relations.

• Willingness to undertake occasional travel.

• Must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodation available for applicants with disabilities.

• Some travel may be required.

• AI-generated insights during the application journey with an opt-out option.