Company: Saama Technologies Inc
Location: Analytical Services, Hinjewadi, Pune, India
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Job Description:
Saama Technologies Inc is seeking a dedicated Clinical Data Manager (CDM) to join our team. In this role, you will oversee data management activities for clinical trials, ensuring compliance with regulatory requirements, industry best practices, and internal standards. You will collaborate with cross-functional teams to ensure the integrity, accuracy, and quality of clinical trial data, ultimately supporting the generation of high-quality, submission-ready data.
Key Responsibilities:
- Data Management Plans: Develop and maintain comprehensive data management plans and validation specifications in line with regulatory guidelines.
- Data Oversight: Oversee the collection, cleaning, and validation of clinical trial data from various sources, including electronic data capture (EDC) systems.
- Quality Control: Lead the design and implementation of data validation and quality control processes to ensure data accuracy and integrity.
- Collaboration: Work closely with clinical, statistical, and programming teams to support database lock activities and generate final analysis datasets for regulatory submissions.
- Protocol Development: Contribute to the development and review of clinical study protocols, case report forms (CRFs), and other relevant documents.
- Vendor Management: Participate in the selection and oversight of external vendors and CROs related to data management activities, ensuring the quality and timeliness of deliverables.
- Industry Trends: Stay updated on emerging trends, technologies, and industry standards related to clinical data management, and propose relevant process improvements.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, or related field.
- Proven experience in clinical data management, particularly within a clinical trial setting.
- Strong knowledge of regulatory requirements and industry best practices in data management.
- Familiarity with EDC systems and data validation processes.
- Excellent analytical skills and attention to detail.
- Strong communication and collaboration abilities.
Preferred Skills:
- Knowledge of sample tracking processes is a plus.