Hybrid Associate Clinical Data Manager

at SDC (Statistics & Data Corporation)

• Job title: Associate Clinical Data Manager
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Hyderabad, India

About the role

• Associate Clinical Data Manager leading data management activities for clinical research studies. Collaborating with internal teams and clients to ensure project success and compliance.

Responsibilities

• Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout as a study lead with some supervision from their line manager or as a backup data manager.
• Manages the day-to-day data management project activities including, but not limited to, timelines, budgets, project scope, reports and communication for the lifecycle of the project(s) working closely with internal team members and clients/partners.
• Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
• Perform/Manage study conduct activities including listing reviews, query management, data transfers etc.
• Perform study closeout activities leading towards database lock.
• Serve as a primary or backup resource to other Clinical Data managers for issues pertaining to data management on multiple studies
• Assist Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
• Mentor all levels of Clinical Data Associates in their job responsibilities
• Maintain quality control of the data, project deliverables and closeouts
• Support and facilitate the review of medical coding for validity and completeness
• Adhere to all aspects of the SDC’s quality system
• Comply with SDC’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Requirements

• Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
• Excellent organizational and project management skills
• Highly effective communication skills, both written and verbal
• Technical skills including EDC systems, clinical data management systems, Microsoft Office
• Additional required skills include the following: CRF design, MS Project, and analytical capabilities
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Benefits

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.