Data Manager

Emmes Services Pvt. Ltd , ("Emmes") is searching for a Data Manager located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position.

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 Data Manager has responsibilities for overseeing and providing technical support to data management projects. The Data Manager is responsible to ensure that the timelines and quality are met for DM deliverables. Serves as a primary point of contact for clinical sites, operations team, sponsor and other stake holders.

Responsibilities

• Provide data management and operational support activities for a protocol or group of protocols. • Possess detailed knowledge of the protocol/s. Collaborates with project teams to identify data collection requirements based on a study protocol. Develop electronic case report forms (eCRFs) and perform user acceptance testing (UAT).

• Review, implement, and evaluate data validation processes; Develop and update study and project materials, including electronic case report forms (eCRFs), Manual of Operating Procedures (MOPs), EDC System User's Guides, Data Management Handbooks, Data Management Plans, Data Validation Plans, project specific Standard Operating Procedures (SOPs) and work instructions; distribute anomaly reports and resolve data discrepancies.

• Participate in site update calls and sponsor calls, as needed.

• Support project statistician to review project-specific reports, as needed.

• Create and maintain documentation on all data-related activities in alignment with project-specific and corporate 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.

• Provide training for internal and external stakeholders on Emmes' EDC systems and data management practices.

• Performs internal data audits and other project quality assurance activities and documents processes as required by corporate/project SOPs.

• Reviews project required reports and contributes to sections as appropriate.

• Demonstrates an understanding of project and corporate SOPs.

• Assists with the orientation of new personnel and serves as a mentor for junior staff.

Experience

• Requires a master's degree in health-related field with a minimum of 6 years related experience

•Strong data management and computer skills

• Self-motivated and detail oriented

• Good understanding of GCP principles and other regulatory standards in Clinical Research

• Ability and self-motivation to undertake leadership role on the clinical data management team

• Excellent organizational and communication (written and oral) skills

• Ability to manage multiple tasks

• Ability to work independently, as well as in a complex team environment

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