Manager, Clinical Data Systems

Overview:

Manager, Clinical Data Systems (Bangalore - hybrid)

Emmes Group: Building a better future for us all.

Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

If you share our motivations and passion in research, come join us!

Primary Purpose

The Manager, Clinical Data Systems is responsible for direct line management of Clinical Data Systems senior staff ensuring that Clinical Data Systems teams are adequately resourced and supported to deliver high quality and efficient Clinical Data Services.

Responsibilities:

• Reviews CDD or BA activities, recommends process improvements, and ensures adherence to departmental standards
• Serves as therapeutic area clinical data system representative in department and corporate meetings; supports new and existing customer relationships and may serve as a CDS representative for external meetings/conferences
• Maintains high-level oversight on data system delivery metrics and CDS deliverables and ensures adherence to departmental standards
• Provides leadership for the CDS team through mentoring, guiding, and coaching
• Contributes to client/sponsor reports and communications on CDS deliverables
• Escalates issues to project leaders as per established project and corporate requirements
• Evaluates contract/proposal to ensure proper staffing and budget on project/program and provides resource allocation support • Provides support for CDS department initiatives and objectives through engagement of CDS staff
• Supports recruitment/retention strategy and related initiatives
• Assesses and monitors new CDS training and documentation; provides department or therapeutic area specific training on CDS processes and procedures
• Establishes open communication and feedback with project leadership on CDS support and performance
• Liaises with clinical operations members in support of client/sponsor
• Models and reinforces the corporate culture through vision, action, and learning
• Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
• Responsible for addressing employee relations issues and resolving problems
• Ensures CDS salary and bonus equity compliance
• Escalates performance issues to CDS leadership
• Approves timesheets, expense reports, and leave request

Qualifications:

• Bachelor’s degree, preferably in public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
• Incumbent typically will possess at least 10 years progressive Clinical Data Systems experience and strong understanding of clinical research and/or Clinical Data Systems processes, including at least 5 years with lead or supervisory experience
• Knowledge of GCP and applicable regulatory guidelines
• Experience in pharmaceutical industry and/or contract research organization preferred
• Experience in clinical electronic data capture (EDC) systems preferred • Knowledge of software development lifecycle activities; experience with Agile/Scrum strongly preferred

• Excellent verbal, written, presentation, and interpersonal communication skills with an ability to inform, influence, and collaborate • Ability to work independently and accept and act with appropriate accountability with minimal guidance
• Strong attention to detail, adaptable, and flexible
• Demonstrated team leadership and supervisory skills
• Ability to execute strategic decisions while balancing competing priorities • Knowledge of Microsoft Office suite is essential

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