Company: Confidential
Job Title: Sr. Clinical Data Manager, Temp
Job Number: 35923
Location: ,
Job Description
The Senior Clinical Data Manager will oversee all aspects of clinical data management, including clinical database design and project oversight, ensuring the quality and accuracy of the database for clinical trials.
Responsibilities
- Coordinate, facilitate, and participate in all data management activities from study protocol initiation through database lock with minimal supervision.
- Provide oversight for outsourced projects and vendor management.
- Support CRF design, review, and clinical database validation.
- Author and maintain project start-up documents.
- Perform user acceptance testing for assigned projects.
- Monitor project progress, conduct data cleaning and QC activities, and ensure timelines are met.
- Prepare data transfer agreements and coordinate the receipt of data transfers.
- Author all database lock documentation for assigned projects.
- Prepare data cleaning and status reports, including metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
- Perform ad-hoc reporting as needed.
- Manage adverse event and concomitant medication coding.
- Oversee SAE reconciliation.
- Provide data management timelines and cost estimates for the project scope of work.
- Contribute to process improvements, data standards, and efficiency initiatives within data management.
- Support a number of moderate to complex trials with minimal supervision.
- Build successful relationships with project teams and provide effective communication to study teams, trial managers, and Biostatistics.
- Interface closely with Biostatistics and Project Management at the project level.
- Provide mentorship to junior-level Data Managers.
- Ensure compliance with applicable regulations, policies, and training requirements.
- Maintain a positive, solution-oriented approach and deliver on additional responsibilities as assigned.
Required Skills
- Bachelor’s degree in a relevant field.
- 5+ years of data management experience in a CRO or sponsor environment.
- Knowledge of CDISC/CDASH standards and EDC systems.
- Familiarity with medical terminology and coding dictionaries.
- Understanding of relevant regulatory guidelines (e.g., ICH, FDA, GCP).
- Experience in biotech, pharma, or medical device industries preferred.
- Prior vocational experience (e.g., internships, fellowships) a plus.
- Strong understanding of clinical trials, pharmaceuticals, devices, and regulatory compliance.
- Proven ability to initiate process improvements independently.
- Successful track record in dynamic, growth-focused environments.
- Intellectual curiosity, innovation, and problem-solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with attention to quality and urgency.
- Hands-on experience and expertise.
- Collaborative team player with experience in smaller working environments.
- Highly organized, detail-oriented, and results-focused.
- Strong communication skills with the ability to simplify technical concepts.
- High professionalism, confidence, and ethical standards.
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