Staff Clinical Data Manager – Clinical Affairs
Company: Stryker
Location: Bangalore, India
Work Type: Full-Time, Hybrid
Req ID: R557551
About Stryker
Stryker is a global leader in medical technologies, committed to improving healthcare and patient outcomes worldwide. With innovative products and services across MedSurg, Neurotechnology, and Orthopaedics, Stryker empowers healthcare providers to deliver high-quality care. Join a culture that values your unique talents and supports professional growth through comprehensive rewards, wellness programs, and performance recognition.
Job Overview
The Staff Clinical Data Manager will play a key role in overseeing clinical data management activities, ensuring high-quality and compliant data collection, analysis, and reporting. You will collaborate with cross-functional study teams to optimize data workflows and contribute to the success of clinical studies, with a focus on medical device trials.
Key Responsibilities
Develop, maintain, and implement data management documentation, including study protocols, CRFs, and data management plans
Design Case Report Forms (CRFs) and configure electronic data capture (EDC) systems for efficient data collection
Perform data entry, cleaning, discrepancy management, and query resolution
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness
Review data from other modules and vendor systems used in the study
Develop and execute SOPs for data entry screen design, validation testing, and approval
Collaborate with study teams to resolve data-related issues and discrepancies
Generate and review data listings, summaries, and reports for clinical study reports (CSRs)
Serve as a primary or backup resource for data management inquiries
Ensure compliance with Good Clinical Practice (GCP), CDISC standards, and regulatory requirements
Contribute to the development and validation of data management software tools
Required Qualifications
Bachelor’s degree in life sciences, healthcare, or related field
Minimum 5 years of experience in clinical data management or similar roles in pharma, clinical research, or medical devices
Proficiency in EDC systems and clinical data management software
Strong knowledge of clinical trial processes, data management principles, and regulatory guidelines (GCP, CDISC)
Familiarity with data analysis and reporting software such as SAS, SQL, and Oracle Clinical
Excellent problem-solving, analytical, organizational, and time management skills
Strong attention to detail with effective communication and collaboration abilities
Preferred Qualifications
Certification in clinical data management (e.g., CCDM)
Experience in CRF design, MS Project, and analytical reporting
Knowledge of CDISC standards and data interchange formats (SDTM, ADaM)
Familiarity with clinical trial design and regulatory guidelines (FDA/CFR, ICH/GCP)
Understanding of data privacy and protection regulations (e.g., GDPR)
Why Join Stryker
Opportunity to work with a global leader in medical technologies
Hybrid work flexibility and collaborative work environment
Comprehensive rewards and benefits, including bonuses, healthcare, retirement programs, and wellness initiatives
Professional development and exposure to innovative clinical and medical device projects
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