Manager Clinical Data Management
9 hours ago
As the Manager, Clinical Data Management (CDM) at KlinEra Global Services, a leading Contract Research Organization (CRO), you will oversee the planning, execution, and management of clinical data management activities across multiple clinical trials. This includes the oversight of data collection, data validation, data quality, and the overall integrity of clinical trial data. You will manage a team of data managers and work closely with cross-functional teams such as clinical operations, biostatistics, and regulatory affairs to ensure that clinical trials are executed in compliance with protocols, regulatory standards, and company policies.
Key Responsibilities:
- Data Management Oversight: Lead and manage data management activities for clinical trials, ensuring timelines, budgets, and quality standards are met.
- Team Leadership: Supervise, mentor, and provide guidance to a team of Clinical Data Managers (CDMs) and other data management staff. Ensure professional development and training opportunities for the team.
- Study Planning: Collaborate with project teams to design and implement data management plans (DMPs), data collection tools (e.g., CRFs), and systems. Oversee the creation of data management documents such as data dictionaries and edit checks.
- Quality Assurance: Ensure the highest data quality by implementing quality control processes. Lead data review activities, such as query generation, resolution, and risk-based data validation.
- Vendor Management: Manage relationships with external data management vendors and provide oversight to ensure service delivery meets expectations.
- Regulatory Compliance: Ensure all data management activities comply with regulatory requirements (e.g., GCP, FDA, EMA) and the company's standard operating procedures (SOPs).
- Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, medical writing, and regulatory teams to facilitate smooth data transfer, analysis, and reporting.
- Reporting and Documentation: Prepare and present reports on data management progress and metrics to stakeholders. Maintain accurate documentation throughout the trial lifecycle.
- Risk Management: Identify potential risks to data integrity and timelines and work with project teams to implement mitigation strategies.
- Technology and Tools: Ensure efficient use of clinical data management systems (e.g., EDC systems, CTMS) and other relevant tools for data collection and analysis.
- Continuous Improvement: Drive continuous improvement initiatives in clinical data management processes to enhance efficiency, quality, and regulatory compliance.
Qualifications:
- Education: Bachelor’s degree in Life Sciences, Medical or Clinical Research, or a related field. Advanced degree (e.g., Master’s) is a plus.
- Experience:
- Minimum of 5-7 years of experience in clinical data management, with at least 2-3 years in a managerial role within a CRO or pharmaceutical company.
- Proven experience in leading and managing a team of clinical data professionals.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical data management.
- Strong experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Experience with clinical trial software and programming languages (e.g., SAS, SQL) is advantageous.
- Skills:
- Excellent organizational and time management skills with a proven ability to manage multiple projects simultaneously.
- Strong problem-solving, analytical, and decision-making abilities.
- Ability to collaborate and communicate effectively with internal and external stakeholders.
- Strong leadership, mentoring, and interpersonal skills.
- Detail-oriented with a commitment to data quality and compliance.
Preferred Qualifications:
- Certifications: Certification in Clinical Data Management (CDMP) or related certifications (e.g., GCDMP) preferred.
- Experience with Global Trials: Experience managing global clinical trials across multiple regions and countries.
- Software Proficiency: Familiarity with clinical data management tools such as Medidata Rave, Oracle InForm, Veeva Vault, and other industry-standard platforms.
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