Job Description
Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, sexual orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.
Senior Clinical Data Manager RESPONSIBILITIES: - Manage Data Management tasks from study start-up to database lock for assigned studies.
- Lead multiple large and complex studies, delegating tasks as needed.
- Interact effectively with sponsors and oversee vendors.
- Mentor junior personnel.
- Develop SOPs and study-specific procedures.
- Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents.
- Work with DB programmers to design (e)CRFs and edit checks in EDC systems.
- Lead User Acceptance Testing (UAT) tasks for complex studies and modules.
- Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation.
- Troubleshoot technical issues and design effective data review processes.
- Manage queries and trends to ensure data completeness and integrity.
- Perform coding of adverse events, medical conditions, and medications.
- Lead pre-lock and data lock tasks.
- Prepare training materials and user guides for EDC data collection tools.
- Provide study-specific training for team members and end users.
- Implement technical solutions and resolve complex issues.
- Provide regular status updates to cross-functional study teams, management, and sponsors.
- Ensure archiving of study databases and related documents.
- Organize and file study documentation.
- Provide input to cross-functional study timelines and resource requirements.
- Assist with identification of project scope changes.
- Present at sales and marketing meetings for prospective clients.
- Develop SOPs and manuals.
EDUCATION: - Minimum BS in a scientific or health-related field or equivalent.
EXPERIENCE: - Minimum 10 years of experience in Clinical Data Management.
SKILLS: - Knowledge of medical terminology and pharmaceutical notation.
- Expertise with EDC systems such as Medidata Rave, InForm, Medrio.
- Excellent organizational and time management skills.
- Strong collaboration and leadership skills.
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