Clinical Data Manager II

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all elements of the clinical trial data management process from the initiation of the study through to post-database lock for designated projects with some supervision.

• Act as the primary Data Management liaison or contributor for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely completion of tasks.

• Conduct data entry and quality control for paper-CRF studies as necessary.

• Contribute to timeline development, ensure that clinical data management deadlines are met with high quality, and evaluate resource requirements as needed.

• Create CRF specifications based on clinical study protocols and coordinate stakeholder reviews and feedback.

• Assist in the construction of clinical databases.

• Execute database build User Acceptance Testing (UAT) and maintain documentation for quality-controlled database builds.

• Supervise overall quality of clinical databases.

• Define requirements for electronic and manual data reviews, as well as other edit checks.

• Generate, modify, version, and maintain data management documentation and oversee the completeness of the Trial Master File.

• Educate clinical research staff and project team members on study-specific CRFs, EDC, and related topics.

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

• Conduct line-listing data reviews and report on patient and study-level statuses and metrics.

• Perform medical coding of medical terms to ensure logical consistency in medical data.

• Coordinate reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Act as a liaison with third-party data and EDC vendors in a project management role.

• Support SAS programming and quality control of SAS programs.

• Identify and troubleshoot operational issues using metrics data, audit reports, and stakeholder feedback.

• Review and provide insights on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) as required.

• Engage in the development and maintenance of Standard Operating Procedures (SOPs) and process documentation.

• Participate in strategy meetings, bid defense preparations, capability presentations, and potential client engagement meetings as necessary.

• Assess RFPs, proposals, and provide project cost estimates as needed.

• Communicate with sponsors, vendors, and project teams regarding issues related to data, databases, and projects.

• Deliver software demonstrations, training sessions, and participate in project meetings as required.

• Carry out other assigned responsibilities.

⛳️ Requirements

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

• Over 5 years of Clinical Data Management experience or proven proficiency in the essential skills for this role.

• Expertise in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.

• Capable of managing diverse clinical research tasks.

• Exceptional organizational and communication abilities.

• Must be proficient in reading, writing, speaking fluently, and comprehending the English language.

• Experience with a clinical database management system is essential.

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

• Willingness to undertake occasional travel.

• Familiarity with dictionary medical coding (MedDRA and WHODrug) is preferred.

• Knowledge of CDISC standards (CDASH, SDTM, ADaM, etc.) is preferred.

• Experience in oncology therapeutics is preferred.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance options.

• Disability benefits available.

• Parental leave provided.

• Paid time off for sick leave and vacation.

• Opportunities for potential occasional travel.