Job Title: Senior Clinical Data Associate
Department: Service Delivery
Employment Type: Full-Time
Location: Bangalore, Karnataka
Company Overview: Sitero LLC is an emerging leader in Clinical services and software solutions for the life sciences industry. With extensive experience across diverse therapeutic areas, Sitero focuses on innovative, technology-enabled solutions that allow clients to focus on their core strengths. From early-phase studies through Phase III clinical trials, Sitero delivers high-touch services and technology to ensure safety, ethics, compliance, and innovation across the clinical research community.
Job Description: The Senior Clinical Data Associate will be responsible for managing and coordinating data management activities, from project setup to database lock. This includes participating in the preparation and review of key documents, serving as the lead data manager on client-facing projects, and ensuring timely and effective communication with sponsors and project teams.
Essential Duties and Responsibilities:
Document Preparation and Review: Contribute to the preparation and review of data management documents, including the Data Management Plan, Data Validation Specifications, and other essential project-related documents.
Project Leadership: Serve as the Lead Data Manager on assigned projects, interacting directly with the client and leading the data management team.
Data Management: Manage all aspects of data management for assigned projects, ensuring the smooth setup, operation, and lock of clinical databases.
Training and Development: Participate in internal and external training programs and provide training to other team members as required.
Client Interaction: Communicate effectively with sponsors and project teams to provide updates on data management activities and address any concerns.
Team Supervision: Supervise the data management team, ensuring efficient project execution and data review processes.
EDC Tool Proficiency: Utilize Medidata Rave or other EDC tools effectively; familiarity with Business Object/JReview is a plus.
Quality Control and Mentoring: Ensure high-quality data management by performing data reviews and mentoring junior team members.
CDISC Standards Implementation: Possess solid knowledge of CDISC standards for clinical data management and regulatory submissions.
Cross-Functional Collaboration: Collaborate with various departments, including medical data reviewers and clinical monitors, to ensure study success.
Documentation and Reporting: Generate project-specific status reports and manage the Trial Master File (TMF) documentation.
Regulatory Compliance: Comply with ICH-GCP, regional regulatory guidelines, and standard operating procedures (SOPs).
Education and Experience Required:
Education: Preferably a life science graduate or equivalent qualification.
Experience: 8-10 years of clinical data management experience within CRO, pharmaceutical, or biotech industries.
Skills:
Proficient in Microsoft Office Suite (Word and Excel).
Strong problem-solving, organizational, and time management skills.
Familiarity with study documentation standards and Trial Master File (TMF) processes.
Experience with CDISC standards, preferably CDISC SDTM.
Ability to work effectively in a fast-paced, global team environment.
Knowledge of ICH-GCP and regulatory guidelines.
Experience in cross-functional collaboration and stakeholder management.
Other: Ability to coach and mentor new team members to facilitate quick onboarding.
Compensation and Benefits: Sitero offers a competitive salary, variable pay, paid time off, healthcare benefits, and retirement plans as part of its impressive compensation package.
Employment Type: Full-Time, Permanent
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