Manager, Data Management

Emmes Services Pvt. Ltd , ("Emmes") is searching for Manager-Data Management 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 Manager of Data Management is responsible for oversight of data management activities,

deliverables, and staff ensuring that Emmes provides the highest possible quality and efficiency of focused

data management support to projects and sponsors that creates value to the project. The Manager may

also perform the role of a Lead Data Manager or a Project Manager.

Responsibilities

  • Provides oversight for data management activities, including:

o Implementation of data management aspects of clinical protocols and data collection systems.

Serves as lead point of contact for both internal cross functional teams and external contacts on

the design, documentation, testing and implementation of clinical data collection studies in an

electronic data capture (EDC) system. May take on the role of a Lead Data Manager for protocol/s.

o Strategic input into proposal or protocol design focused on data management considerations.

o Mitigation of potential data management issues by reviewing protocols for cross-project

consistency and identifying standard case report form modules to meet objectives.

o Reviewing DM activities and recommending process improvements.

o Maintaining high-level oversight on data quality metrics and DM deliverables.

o Identify and quantify resource requirements for ongoing and future projects.

o Manage billable and non-billable time for the data management group if requested.

o Review project-specific reports and supports drafting of study progress reports.

o May represent Clinical Data Management team at business development, sponsor meetings and

professional meetings.

o Participate in internal or agency audits and inspections.

o Demonstrates an understanding of project and corporate SOPs.

o 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.
  • Project Satisfaction Management:

o Establishes open communication and feedback with project leadership on DM support.

Establishes open communication and feedback with project leadership on DM support. Evaluate contract/ proposal to ensure proper staffing on overall project and provide resource

allocation support.

o Escalate issues to project leaders as per established project and corporate requirements.

o Liaise with clinical operations members in support of client/sponsor.

o Contributes to client/sponsor reports and communications on DM deliverables.
  • Direct Report Management:

o Provides leadership for the DM team through mentoring, guiding, and coaching.

o Develops/oversees recruitment/retention strategy and related initiatives.

o Approves timesheets and leave requests.

o Collaboratively conducts performance and compensation review activities with the applicable

project leader or designee.

o Responsible for addressing employee relations issues and resolving problems.

o Escalates performance issues to DM leadership.

o Assesses and monitors new DM training as documented on the orientation checklist.
  • Provides support for DM SG initiatives and objectives through engagement of DM staff.
  • Models and reinforces the corporate culture through vision, action, and learning.
  • May be required to facilitate or present at meetings, conferences, and other events representing Emmes, including job fairs or other external events.
  • Develops and implements data validation processes. Ensures the integrity of data, providing

recommendations for corrective action when necessary.

Experience
  • Bachelor's or Master's degree (preferred) in health-related field, with at least 11 years of related data management experience in a medical/biologic or other health within pharma and/or CRO.
  • 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 communication, presentation, interpersonal skills, both written and spoken, with an

ability to inform, influence, convince, and persuade.
  • Strong data management and computer skills.
  • Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. 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
  • Must have a good understanding of clinical database structures, and data management processes.
  • Excellent verbal and written communication skills
  • Strong attention to detail and flexible
  • 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.

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