Manager, clinical data management

Project Role : Manager, Clinical Data Management

Work Experience : 8+ years

Work location : Kochi

Mode of work : Hybrid

Job Overview

Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.

Essential Functions

• Provide expert review and guidance for production of Data Management deliverables including CRF / e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development / training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses.
• Hold at least bi-monthly meetings with direct reports to discuss, at a minimum : project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.
• Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.
• Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.
• Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.
• Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.
• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
• Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.

Qualifications