Job Description

Emmes Services Pvt. Ltd , (“Emmes”) is searching for Senior Data Manager in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position. EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
Primary Purpose The Senior Clinical Data Manager is responsible for data management oversight activities for research studies. The Senior Clinical Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Senior Clinical Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as primary point of contact with internal and external project teams on all aspects of data collection.
Responsibilities

• Collaborates with cross-functional teams and facilitates the design, documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system

• Creates and/or reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner

• Determines data collection requirements based on the study protocol and system knowledge, makes recommendations based on previous experience

• Proactively identifies potential data management issues/risks and recommends/implements solutions

• Manages data collection and data validation at participating clinical sites

• Manages training documentation and provides oversight of system user access, may serve as resource for troubleshooting system issues

• Creates and/or reviews study data management documents (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)

• Independently monitors own activities and project status for successful project deliverables according to timelines

• Manages data reports and creates data summaries or presentations as applicable

• Manages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelines

• Manages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources

• Bachelor's degree in scientific discipline preferred with a working knowledge of the clinical/scientific terminology and methods.

• Incumbent typically will possess at least 6 years progressive experience, or Master's degree and 4 years progressive experience working in a clinical research environment, with basic understanding of the clinical development and data management processes; or equivalent combination of education and experience

• Knowledge of MS Excel, Word, Access, and PowerPoint is essential.

• Proven data management skills

• Excellent verbal and communication skills

• Self-motivated, reliable team member

• Strong attention to detail and flexible