Senior, Data Management

Emmes Services Pvt. Ltd , ("Emmes") is searching for Senior Clinical 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 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
collaborates 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 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.
• Provides training to the site/CRA users on EDC and eCRF completion. 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.

• Performs data review and query identification/resolution, manages data quality metrics for a protocol

or project.

• Attends and contributes to project and functional group meetings, may serve as DM representative

on external calls as required.

• Mentors staff on project-specific clinical data management processes, provides data management

expertise at a project level.

• Performs internal data audits and other project quality assurance activities and documents processes

as required by corporate/project SOPs.

• Participate in corporate QA meetings with the Internal Quality Audit Team (IQAT), ensure adherence

with project-specific SOPs and compliance/variance table, and participate in internal/external audits,

as required. Ensure adherence to GCP and ICH guidelines.

Experience

• Bachelor's or Master's degree (preferred) in health-related field, with at least 4 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 with site training.
• 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

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.