Job Description

Emmes Services Pvt. Ltd , (“Emmes”) is searching for Associate 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 Associate Clinical Data Manager is responsible for assisting with data management activities for research studies. The Associate 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 Associate Clinical Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and collaborates primarily with internal project teams on all aspects of data collection.
Responsibilities

• Assists cross-functional teams with the documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system
• Contributes to design and/or development of study-specific electronic or paper Case Report Forms (CRFs), utilizing study protocol and clinical requirements
• Assists the project team and other study personnel to determine data collection requirements based on the study protocol

• Assists with documenting and resolving data management issues in conjunction with the DM team
• Assists with review, implementation, and evaluation of data validation processes (e.g. edit checks)

• Utilizes 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)
• Assists with reviewing data obtained through Electronic Medical Records (EMR) integration, EDC systems, or other external data sources
• Assists with data quality audits
• Attends and participates in project and functional group meetings as required

• Assists with identification and resolution of data queries and discrepancies

• Assists with training users on the EDC system and protocol specific EDC requirements, maintains related training documentation and supports system user access

• Assists with preparation of data reports as applicable

• Bachelor’s or Master’s degree (preferred) in health-related field, with at least 2 years of related data management experience in a medical/biologic or other health within pharma and/or CRO.
• Strong data management and computer skills.
• Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
• Demonstrated strong problem solving and analytical skills, combined with sound business judgment.
• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
• Highly motivated with ability to work independently and as part of a multi-disciplinary team
• Excellent verbal and written communication skills
• Experience in therapeutic research areas that will align with Emmes’ expertise, including ophthalmology, oncology, vaccine and infectious disease, transplantation or cellular therapy trials, autoimmune disease, neurology, substance use, maternal child health is preferred