Ashad Ali

Experience Snapshot: Project Manager

• Oversaw high profile projects for by planning, designing, and scheduling phases.
• Participate in Client and Team meeting as needed.
• Eliminated discrepancies in progress by reviewing performance, spend and timeline.
• Create and implement Case Report Form and review Imaging data for respective studies.
• Assist external service providers in data transfer and reconciliation processes.
• Serve as liaison with radiologists at academic centers and work towards resolving any issues that arise during clinical trial.
• Assist in preparation, execution, and documentation of User Acceptance Testing (UAT) related to data management aspects.
• Support planning for image evaluations and data transfer processes.
• Developed and initiated projects, managed costs, and monitored performance.
• Manage and Develop Team Capability
• Oversee day-to-day activities and task management of project team to ensure that focus om quality, budget and timelines on each project is reached and maintained.
• Ensure proper documentation of procedures according to SOP.
• Lead and motivate team according to organizational goals.
• Manage and appraise all staff under jurisdiction.
• Deliver Project to Quality, Timeline and Budget Requirements.
• Plan, implement and deliver project in accordance with contract with sponsor.
• Manage project in timely manner in adherence with IOCN SOPs, SSPs and appropriate regulations and liaise with other departments and project managers as necessary to achieve this.
• Determine best method to resolve data errors and inconsistencies.
• Prepare and manage overall project budget throughout life cycle of project, taking over-all responsibility for cost control, timeline and project quality.
• Continually review project contract in order to ensure that any out of scope work is managed promptly and efficiently.
• Met project deadlines without sacrificing build quality.

Experience Snapshot: Manager

• Manage local data management department to ensure project objectives are met within budget and to agreed timelines.
• Manage clinical data management staff as appropriate, including but not limited to resource planning, recruitment, performance evaluations and training.
• Responsible for managing clinical data management function under general direction of Director or Data Management.
• Onboarded new employees with training and new hire documentation.
• Conducted monthly inventories of raw materials and components on work floor.
• Achieved or exceeded financial goals on regular basis by controlling expenses, optimizing schedules and regulating inventory usage.
• Recruited and hired top performers to add talent and value to department
• Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals
• Cross-trained existing employees to maximize team agility and performance

Experience Snapshot: Data Management

• Mentored and guided employees to foster proper completion of assigned duties.
• Conducted training and mentored team members to promote productivity, accuracy and commitment to friendly service.
• Built strong relationships with customers through positive attitude and attentive response.
• Established open and professional relationships with team members to achieve quick resolutions for various issues.
• Ensure completion of Data management activities as executed by Data Managers.
• Contribute towards improvement in process, quality and efficiency to decrease manual efforts.
• Ensure Adherence to project level SLAs and KPI.
• Face Internal, Client or Regulatory audits and assist in closure of findings wherever applicable.
• Responsible for overall quality of deliverables from Data management team.
• Perform Operational QC (sample QC) for DM deliverables.
• People management and resource/work allocation across projects.
• Ensure accurate completion and maintenance of internal systems, databases, eTMF, EDC tool

Experience Snapshot: Medical Imaging

• Conduct quality assurance checks on study data.
• Validate and manage study database, including Subject/Lab, AE/SAE/Images, and review results for assigned projects.
• Ensure that site personnel have comprehensive understanding of study protocol and requirements to fulfill their obligations accurately.
• Utilize established image processing techniques, such as downloading imaging data from external sources, measuring regions of interest, and performing video system-specific processing, across various modalities such as CT, MRI, Nuclear Medicine, and Ultrasound. This is done using proprietary software (Alice) as well as other relevant third-party packages.
• Provide mentorship and assistance in training internal staff members.
• Assist in preparing and presenting Operations overview during client investigator meetings to ensure team is well-informed about ongoing results.
• Conduct preliminary reviews of measurements
• Monitor compliance with Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), departmental and company-wide SOPs, and specific protocols within assigned projects.

Experience Snapshot: Medical Imaging

• Interact with wider stakeholders, e.g. CROs/vendors and monitors
• Input into study plans and process documents.
• Assist with preparations and present for Operations overview at client investigator meetings to ensure that team is well informed of ongoing results.
• Conduct image data review against basic parameters (QC) vs Protocol.
• Assure quality of deliverables, site management and Query management
• Proactively track timelines and identify issues in order to propose strategies to implement contingencies and risk planning to meet overall study/program goals