Clinical Data Manager II

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

📋 Description

• Oversee the entire clinical trial data management process from the initiation of studies to post-database lock for designated projects, with some supervision.

• Act as the primary Data Management contact and/or contributor for assigned clinical projects or programs.

• Execute data entry for paper-CRF studies and carry out quality control of data entry as necessary.

• Contribute to timeline development and ensure adherence to clinical data management deadlines while maintaining quality.

• Evaluate resource requirements for assigned projects as required.

• Create CRF specifications based on clinical study protocols and manage stakeholder review and feedback.

• Assist in the construction of clinical databases.

• Conduct User Acceptance Testing (UAT) for database builds and maintain quality-controlled documentation related to database construction.

• Ensure the overall quality of clinical databases.

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

• Draft, revise, version, and maintain data management documentation while ensuring the completeness of the Trial Master File.

• Train clinical research personnel and data management project team members on study-specific CRFs, EDC, and associated materials.

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

• Conduct line-listing data reviews.

• Generate reports on patient and study-level status and metrics.

• Carry out medical coding of medical terminology.

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

• Collaborate with third-party data and EDC vendors in a project management capacity.

• Provide assistance with SAS programming and ensure quality control of SAS programs.

• Identify and resolve operational issues through the analysis of metrics data, audit reports, and feedback from stakeholders.

• Review and offer input on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) as needed.

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

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

• Assess RFPs, proposals, and provide project estimates.

• Communicate effectively with sponsors, vendors, and project teams regarding data, databases, and project-related issues.

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

• Perform additional duties as assigned.

⛳️ Requirements

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

• At least 5 years of experience in Clinical Data Management or a demonstrated aptitude in the essential skills required for the position.

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

• Capable of managing a diverse range of clinical research tasks.

• Exceptional organizational and communication abilities.

• Must be fluent in reading, writing, and speaking English to facilitate effective communication within Precision for Medicine and with clients.

• Experience in employing a clinical database management system.

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

• Willingness to undertake occasional travel.

• Candidates must be legally authorized to work in the country of employment without requiring employer sponsorship.

• Preferred: Familiarity with dictionary medical coding (MedDRA and WHODrug).

• Preferred: Knowledge of CDISC standards (CDASH, SDTM, ADaM, etc.).

• Preferred: Experience in oncology therapeutics.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Equal opportunity employment.

• Reasonable accommodation during the application process.