Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.• Define and prioritize resource requirements and manage resource assignments across projects.• Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance.• Propose salaries, promotion and termination actions. Actively contribute to recruitment of new staff.• Implementation of… Show more Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.• Define and prioritize resource requirements and manage resource assignments across projects.• Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance.• Propose salaries, promotion and termination actions. Actively contribute to recruitment of new staff.• Implementation of department/office objectives.• 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.• Attend customer meetings and lead discussions of project requirements and strategic planning.• Understand scope of work, budget, and scope assumptions.• Identify out-of-scope work and provide revised costs with supporting documentation.• Ensure project milestones are met according to agreed upon timelines. Actively manage quality throughout project.• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. Show less

• 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 the Clinical Data Base from Study Start-up to Close-out. • Develops and implements data validation processes. Ensures the integrity of data, providing recommendations for corrective action when necessary.•… Show more • 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 the Clinical Data Base from Study Start-up to Close-out. • Develops and implements data validation processes. Ensures the integrity of data, providing recommendations for corrective action when necessary.• Providing timely and professional management of clinical trial data with respect to cost, quality delivery (RTP (Release to production), Snapshots and Database Locks (interim and final)) and timelines for assigned trials managed within Clinical Data Management.• Mitigation of potential data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives. • Reviewing DM activities and recommending process improvements. Reviewing CRFs and DMP documents which includes Edit specification Document, Project Plan, CRF Completion Guidelines, Non-CRF Data Guidelines, SAE Guidelines, Quality Plan, EDC Cleaning Plan and Report Specification documents.• Expert in handling vendor data like Local Lab Data, SAE data, Central Lab Data & IVRS Data.• Providing data solutions to manage protocol amendment and post-production changes in EDC. • Identify and quantify resource requirements for ongoing and future projects. Manage billable and non-billable time for the data management group if requested. • Maintaining high-level oversight on data quality metrics. Demonstrates an understanding of project and corporate SOPs.• Establishes open communication and feedback with project leadership on DM support.• Provides leadership for the DM team through mentoring, guiding, and coaching. Show less

• Serve as Data Team Lead for two global studies in a leadership role to all DM Task including Labs, External vendor data handling and Programming.• Manage delivery of projects through full data management study life-cycle.• Meet objectives as assigned. Prepare project plans, DMP – Data Management Plan documents, review Protocol and give feedback, Write edit check specifications, support DOC, Vendors, Programmers, CRAs and stats providing clarifications when required, Follow-up on… Show more • Serve as Data Team Lead for two global studies in a leadership role to all DM Task including Labs, External vendor data handling and Programming.• Manage delivery of projects through full data management study life-cycle.• Meet objectives as assigned. Prepare project plans, DMP – Data Management Plan documents, review Protocol and give feedback, Write edit check specifications, support DOC, Vendors, Programmers, CRAs and stats providing clarifications when required, Follow-up on project status, conduct Internal and External meetings, Customer interactions, • Develop and maintain good communications and working relationships with Project team. • Interact with sponsors to negotiate timelines and responsibilities. Train CRAs on eCRFs. • Review budgeting and provide estimations and feedback. • Provide timely feedback to the internal project team (DOC, Coders and Programmer) to have a healthy knowledge sharing and add to their individual development.• Have been indulged in Line Management activities like conducting team meetings, Project Review Meetings, Activities Initiative meetings, Reviewing Resource allocation sheet, Trainings on topics general across projects and Metrics meetings. This was mostly like a functional Line Manager Role. Show less