SUMMARY

• Accomplished Project Manager with a proven ability to develop and implement project and operations management strategies for the team Operations that support project and business objectives od project teams. Develop and manage projects complete life cycle from beginning to end including project scope, timeline, capacity planning, resource allocation and project execution.
• Managing Project Budget (10M$) through regular forecasting the project needs and allocating budget based on the requirements
• As an Operations Manager, involved in Resource allocation and Capacity Planning for clinical data management team.
• Project and PMO - operations Management. Project Manager who responds to shifting Business needs and priorities in a systematic and effective way.
• Heading from a clinical, life science and management background - have acquired high expertise in operations management in multiple domains including Pharmaceutical, Customer support, clinical analytics and Commercialization domains.

PROFESSIONAL EXPERIENCE

Confidential

Project Manager

Responsibilities:

• Develop local knowledge of site (and local SMO) capabilities and past performance, and ensure local site / SMO related information is current.
• Interacting with stakeholders across the to prepare and deliver high quality contents to the clients and customers.
• Planning the budget for the commercialization team and allocating the budget for the commercial and medical teams. Acting as one point contact for the multiple biomarker process.
• Providing team support and coordination in team meeting, vendor meetings includoing-preparing meeting Agendas, sending Minutes and following the risks and escalations.
• Collaborate with internal & external partner(s) to develop, implement, and track: Launch readiness plans, and Customer training programs.
• Identifying Key Deliverables, resource planning and Periodicity for the Deliverables
• Develop and track project schedule and Key Performance Indicators (KPIs)
• Facilitate cross-functional, cross-matrixed team meetings and work sessions across the teams in biomarker.
• Support the development of marketing materials and ensure timely approval of materials in accordance with regulatory requirements.
• Support development of presentation materials for key communications and meeting

Confidential

Operations Manager

Responsibilities:

• Develop and manage projects complete life cycle from beginning to end including project scope, timeline, capacity planning, resource allocation and project execution.
• As an Operations Manager, involved in Resource and Capacity Planning for clinical data management team.
• Documenting Project status reports and Deliverable updates all operational changes and initiatives of the project team.
• Clinical Trials Intelligence - Capturing and maintain a database of all the trials across the globe from various sources and registries. It covers all the important parameters of trials such Protocol title, summary, description, eligibility, identifiers, study design, interventions, and protocol measures.
• Executing, analysing and interpreting results and documenting the reports for the Product companies across the globe with in the deadline.
• Providing leadership and technical support for Analysts in completing of daily activities. Providing feedback to analysts on their performance to improve efficiency.
• Providing inputs to ensure consistency and accuracy of protocols, Data validation, Manual Validation, Data handling plans, Data transfer Specification for the assigned product analysis.
• Prepare Scope of work, quotes and budget and share to the client for approval.
• Managing risk, budget, time and stake holders at all levels.
• Executing, analysing and interpreting results and documenting the reports for the Process across the globe with in the deadline.
• Building project portfolio and Knowledge databases for the projects.
• Providing inputs to ensure consistency and accuracy of protocols, Data validation, Manual Validation, Data handling plans, Data transfer Specification for the assigned product analysis.
• Provide frequent on-site monitoring and vendor quality, inspect prospected and completed tasks in accordance to the corporate standards and procedures and ensure proper follow-up.
• Facilitate formal turn-over with onsite team, support partners and monitor deliverables until agreed upon project milestone is achieved.
• Provide project management and direction to ensure the project team has a clear understanding timelines, risks, escalation path and roles/responsibilities they will undertake within the project and the team.
• Recruited of project staffs and consultants; manage coordination of partners and working groups engaged in the project.
• Experience in the design and implementation of new projects oriented to increase customer satisfaction by delivering high-quality products and continuously expanding the coverage of our scientific databases, as well as in the improvement of processes to increase efficiency, timeliness, and quality by applying Six sigma principles and techniques.
• Product-driven decision-making abilities and capability to lead changes quickly adapt to company strategic decisions.

Confidential

Principal Scientific Analyst

Responsibilities:

• Performed Clinical Data Review and analysis to provide abstraction and analysis of Chemical data and Biological to Data to the Scientists and Researchers across global locations.
• Responsible for defining, creating, modifying, measuring and reporting key citations and indicators including analysis, and documentation of clinical site selection analysis and Activation process.
• Assist with the development and continual Improvement of clinical processing activities.
• Act as the point of contact to all data management deliverables, Review data listings and guidelines of the Clinical analysis team and drug database team.
• Standard Operating procedures (SOP’s) for different Functionalities of the projects were documented and developed to a Guidelines for the team to refer in case of clarifications is required.