Dr Ashwin Dhollu

As Oversight Manager:

• Responsible for project management and Oversight of all data management services for complex Oncology and Neurology projects. Primary point of contact for customers, vendors, and senior management.
• Primary liaison role for molecule including representation on Governance committees and input to Partnership Operating Manual (POM).
• Responsible for financial management of assigned projects, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed.
• Part of F2F Sponsor meetings and Governance calls.
• Prepares input for and participates in proposal bid defense meetings.

As Staff Development Team India POC:

• Subject matter expert (Product Expert) for project specific updates, guidance document creation and providing project specific trainings to internal and external audiences as required.
• Evaluated emerging trends and technologies in field of data management, making strategic recommendations for long-term growth and innovation.
• Fostering Innovation through “Innovathon” (created Logo and tagline), successfully executed idea generation workshop (evaluation and implementation).
• Development of departmental technologies, SOPs, processes, and procedures.
• Represent Data Management in company-wide initiatives.
• Trains and mentors’ data management staff, develops and delivers applicable data management departmental training.

As Line Manager:

• Handling UAT process and UAT, SDTMv and AERO UAT resourcing for all studies.
• Line Management responsibilities for team of 15+ team members.
• Mentored junior staff members, providing guidance on career development opportunities, and promoting professional growth within team.
• Played key role in driving organizational change initiatives related to data management policies and procedures, resulting in streamlined operations.
• Delivered presentations to senior leadership on value proposition of data management, securing buy-in for key initiatives and investments.

Managerial Responsibilities –

• Leading high performance clinical data management projects across international and multi-cultural organizations & collaborating with cross-border teams.
• Good people management skills, handled team of 70+ associates ensured that work delivered as per schedule.
• Effective Project Management, tracking and monitoring of risks and study level metrics and overseeing multiple projects (molecules).
• Plan/ensure/drive continuous process improvements and innovations across teams and projects.
• Revenue projections/budget forecasting, FTE estimation, billing, effort estimation, Project/Study budgeting, tracking and creation of Cost drivers.
• Preparing business case for new RFP, SWO/Work Order/Change Order management.
• Improve customer satisfaction and score in at least one identified parameter-Identifying and implementing robotic automation within process.
• Agile Scrum Master for end-to-end study build and ensure implementation of Agile framework in applicable study phases.
• Monitor and instrumental in achieving timelines. SLA and KPIs (Key Performance Indicators).
• Perform annual performance appraisals and provide regular constructive feedback.

Onsite Business Transition (Europe)

Part of RFP (Request or Proposal) team @ Basel, Switzerland, for Business transition – New project transition for CDM – Set-up and Start-up.

Key Accountabilities – Technical

Set-up phase in CDM:

• Setting up a study in RAVE database end to end right from creation of documents like Data management plan (DMP), SLACS, Visit matrix (VM), Project plan, Data Validation specifications (DVS), Protocol deviation document, eCRF guidelines, Sample reconciliation setup, IVRS setup, Spotfire, SAS utility tools etc.
• Migration/Protocol amendment activities.
• Prepare process flow, creation and maintenance of Project planners and SmartSheets

Conduct and Close-out phases in CDM:

• Validation of clinical data generated from trials and making sure that data is all set for further analysis by Biostatisticians and study team.
• Prepare issue log and action log trackers for site, study team and monitors.
• Working on Data management trackers along with scientists, core data management team and study leaders
• Coding activities, SAE reconciliation, Third Party Data Reconciliation.
• SPOTFIRE tool – Validation and creation of reports
• Sample Reconciliation, IVRS/IWRS/PRO data reconciliation

Therapeutic Area Expertise:

• Oncology, Neuroscience, COPD, Immunology, Virology, RA, Diabetes, etc. across all phases, end to end.
• Worked on over 90 studies till date across clients and achieved more than 40 database locks.
• Expert for RAVE and Part of Global standards team for Oncology trials.
• Certified Train the Trainer for Sample reconciliation.
• SME for Rave Study build, Spotfire Visualization creation and SDCRe process.

Responsibilities :

• Perform data management E2E activities for assigned studies as per scope of task and role assigned.
• Performing Protocol review, eCRF designing, UAT, Data Validation, Query Management, Medical Review, SAE Reconciliation, Coding activities and Narrative writing for assigned projects.
• Providing inputs for process improvements in CDM process.

Achievements : Received "Roll of Honor" award for outstanding performance.

Responsibilities: Understanding customer's heath concerns and providing with right supplements. Multi-tasking and prioritize handling of issues in high stress/high pressure work environment.

Responsibilities: Review inconsistencies and mistakes in medical terms, referring to dictionaries, drug references and other sources on anatomy, physiology and medicine.

Responsibilities : Case taking, Case analysis, diagnosis, prescribing, counseling and dispensing medications.