Stryker
Staff Engineer - Clinical Data Management
Company
Role
Staff Engineer - Clinical Data Management
Location
India
Job type
Full-time
Found on Mokaru
Yesterday
Salary
Job description
What will you do:
Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
Perform data entry and cleaning activities, including discrepancy management and query resolution.
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Conduct data review from other modules and vendors utilized for the study.
Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
Collaborate with study team members to resolve data-related issues and discrepancies.
Generate and review data listings, summaries and reports for clinical study reports.
Serve as a primary or backup resource for issues about data management.
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
Contribute to the development and validation of data management software tools.
What will you need:
Basic qualifications:
Bachelor’s degree in a scientific or healthcare-related field.
Minimum 5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry. Experience in medical devices company is preferred.
Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
Proficiency in electronic data capture (EDC) systems and clinical data management software.
Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
Excellent attention to detail with problem-solving and analytical skills.
Strong organizational and time management abilities.
Preferred qualifications:
Certification in clinical data management (like CCDM).
Knowledge of CRF design, MS Project and analytical capabilities.
Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
Understanding of data privacy and protection regulations (e.g., GDPR).
Effective communication and interpersonal skills to collaborate with other teams.
