Rahul Dawkhar

• Acts as study leader for multiple studies individually or as program of studies
• May perform Project Manager role for standalone studies
• Responsible for functional, administrative, and financial oversight of assigned projects
• Acts as a primary liaison for project team and client
• Monitor, evaluates and proposes mitigation strategies surrounding risk to deliverables and finances
• Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required
• Additionally, promote repeat business by developing relationships with new and existing clients
• May develop and implement study-specific training for DM project staff and performs independent reviews of DM deliverables following CDM guidelines
• Perform project forecasting of hours, identify resource requirement, manage project budget (includes identifying out of scope work) and participate in Contract Modification process
• Participate in development/ implementation of processes, procedures, and training for data management function as directed
• Provides support and coaching to DM team to ensure that all tasks are completed accurately, on time and within budget to meet or exceed client expectations
• Mentor junior level staff on all associated tasks within study or program
• Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality, and budget.

• .Serve as primary point of contact for customer on data management deliverables; manage multiple large studies or program of global studies.
• Provide leadership and senior support to DTLs on multiple large global studies/programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and Quintiles management to independently manage and meet contractual obligations.
• Manage Data Operations Coordinator (DOC) and/or Data Operations team members and meet on a regular basis to ensure milestones meet timelines and quality deliverables; provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects.
• Serve as the escalation point for unresolved data issues; independently work with client data managers, vendors, internal team members for resolution.
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and/or review and sign-off on all key data management documents
• Ensure service and quality meet agreed upon specifications per DMP and contract/SOW.
• Implement proactive quality management plans across multiple projects/programs/customer account.
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service; develop and work with team to implement plan to re-organize and drive change (possibly across customer account).
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME) - Provide leadership and expertise in specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise; may coordinate work of more junior DTL staff.
• Independently maintain internal tracking databases and systems.
• Financial Management/Business Development Support: Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Independently manage SOW/budget - Review financial reports monthly and participate in project reviews as requested - Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense).

• As Project Manager on Clinical Studies and supporting Clinical Data Management Process and Clinical Systems
• Bringing new tools and process optimization within organization
• Chair/Participate in Project meetings and manage key deliverable in timely manner
• Manage end to end activities for assigned multiple projects (4 to 5 projects in parallel)
• Data Overview using various tools and Data mining as well using excel, sas reports etc
• Vendor and stakeholder management
• Handling study invoice and change orders including study budget overall
• Coordination of all delivery with input from Data Manager, Clinical Operations Specialist, Clinical Trials
• Administrator, and Medical, Safety, etc
• Risk Detection and Management including CAPA analysis
• Identify and contribute to areas of best practice and process improvements, SOP review/writing etc.

• Work with Study groups at Headquarters for Clinical Data Management activities.
• Review Study Outline, Protocol and define complexity of trials and scope of study design during review rounds.
• Participate in vendor selections and scrutinizing vendors (Bid Defense Meetings) for outsourced projects.
• Manage multiple projects in parallel and perform oversight of CRO activities.
• Responsible for process and delivery during Study Design/Conduct/Closeout phase and perform all study startup activities.
• Handle multiple stakeholders and ensure completion of deliverable agreed in Contracts finalized post BID Defense meetings.
• Handle trial master file (e-TMF) including QC of documents, file review and document approvals.
• User administration, review of data, system up versioning.
• Work with submissions and market access group for drug launch preparation activities.
• Ensuring Study Design and Final study data comply as per CDISC and SDTM standards.
• Conduct (weekly-fortnightly) Meetings within study groups, Vendors, in-house programmers, coding, safety team etc.
• Update Management on Progress of Projects and upcoming milestones through dashboards, presentations, trackers etc.
• Coordinate with Stud Group and external partners until successful DBL and Study Reports
• Participate in Study result meetings and share overall learning on Project within department/Project.
• Handle invoices, billing and forecast budget for trials assigned and discuss same with Group Head
• Training Sites, monitors, study group Members on EDC or more systems involved.
• Presenting at Investigators Meeting.
• Training and support to all users on clinical systems like EDC, e-TMF, SharePoint etc.
• Globally Facilitate Face to Face Meetings within study group, external vendors at Headquarters.

Performed Line Management for team ranging from 10-15 members with multiple (8 to 10 Oncology projects) phase 1,2 and 3 studies with 5+ years of experience

• Review and Creation of project SOPs, templates, study document for clinical studies
• Manage Set-up of EDC studies, Conduct, Closeout and Submission with high quality standards
• Managing resource requirements and billing/invoices for assigned projects
• Coordinating within internal and external stake holders (including third party vendors)
• Coordinating work with Stats & programming, trial management, market access team, site monitors etc
• For timely delivery of milestones
• Manage high quality delivery for assigned projects for Data Validation, Discrepancy handling, raising, and reviewing queries
• Defining Qualitative parameters and master project plan for all assigned projects
• Supervising day to day activities within team and responsible for quality and delivery of projects
• Doing Appraisals, one to one feedback, training plan and goal setting for team members
• Ensuring submission activities for final study data per CDISC and SDTM standards
• Maintaining various study metrics, reports, and documents for Project Overview
• Facilitate/ Lead and conduct meetings from study start up to Study Closure with internal and external stakeholders
• Oversee CROs for assigned projects and have regular progress meeting and feedback from team.
• Act as point of contact for escalations within organization for assigned team and projects
• Process trainer and certified Trainer for Clinical systems and processes.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.

• Data review and Discrepancy management for assign studies.
• Query Management for assigned projects by Team Leader.
• Study Status tracking and collaborating with support teams like coding, programming, etc.
• Perform ongoing Data Cleaning cycles for consistency and High Quality of data throughout Conduct Phase.
• Issue follow-up with all applicable stake holders and tracking until resolution.
• Handling Technical issues in collaboration with tech/Support teams.
• Performing Manual/SAS checks and documenting comments with actions applicable in Database etc.
• Providing Clean Patient Tracker, Study Metrics reports, Billing, Missing Pages Report, etc.
• Resolution of Site, Monitor and Study Team queries.