- Serve as the Study Data Manager on all aspects including proactive communication with other team members to ensure consistent cohesive data handling and quality.
- Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration, discrepancy management; to ensure that internal and client quality standards are achieved.
- Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
- Perform medical coding of Adverse Events and Concomitant medication.
- Take on responsibility for program of studies to ensure the Data Management aspects of a study and associated documentation are consistent across studies and ensure Data Management staff are trained in client specific requirements.
- Perform CRF / eCRF review for Phase I, Phase IIa, large and complex clinical studies.
- Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate.
- Attend study initiation meetings.
- Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
- Support the training of staff on project-specific, global and standardized data management processes; to include end-user training on clinical database systems and performing QC of individual's work.
- Assist in training other members of the department, other Covance employees, or Sponsor representatives as appropriate.
- Make decisions on a daily basis to ensure that studies remain on schedule and data quality remains high. Understand the impact of those decisions, weigh options accordingly and discuss with other team or department members as appropriate. Explain and negotiate with internal and external customers as required.
- Communication with other team members to ensure consistent cohesive data handling and quality.
- Mentor and provide support to Data Management supervisors on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
- Develop and maintain strategic client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
- Work closely with supervisor to review work coming into the department and participate in scheduling, so that the correct resource is assigned to each study at an appropriate time.
- May serve as backup to the CDARO Project Manager.
- Create interim listings for dose escalation and safety assessments as needed.
- Have input in writing, reviewing and updating SOPs and associated documents as required.
- May design and review Case Report Forms.
- Maintain accurate records of all work undertaken.
- Performs any other duties as assigned Education: * University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Qualifications: Minimum Required:
- Typically 4-5 years of applicable clinical research experience in data management.
- Additional experience may be substituted for education requirements.
- Knowledge of clinical database systems is highly preferred.
- Knowledge of medical terminology and medical coding experience preferred.
- Knowledge of data management preferred.To find out more about Real please visit www.realstaffing.com
Real - 20 months ago
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