Vikas Pal

#Project management:

• Successfully managed multiple concurrent clinical trials by prioritizing tasks based on urgency, resources, and strategic goals.
• Led Phase I dose-escalation and Phase III–IV clinical studies across oncology, psychiatry, rare diseases, and general medicine for USFDA, EMA, and DCGI submissions, covering indications such as multiple myeloma, breast/ovarian/bladder cancer, multiple sclerosis, and anemia.
• Reviewed Phase IV Post-Marketing Surveillance studies in Oncology for regulatory submission to DCGI.
• Created trial timelines from start to close-out, including ethics approvals, patient visits, and database lock, with proactive tracking and delay mitigation
• Implemented innovative strategies to boost patient recruitment and retention, improving enrollment rates and reducing dropouts in clinical studies.
• Met project deadlines without sacrificing build quality through risk assessments.
• Established clear and consistent communication among team members, study sites, sponsors, and internal departments through regular updates, fostering collaboration and contributing to the successful and timely completion of projects.

#Start-up Management:

• Feasibility: Assessed site feasibility based on protocol, patient population, and infrastructure; negotiated budgets and contracts with sites and vendors.
• Site Selection: Conducted site visits to assess capabilities, staff qualifications, and regulatory compliance for optimal site selection.
• Regulatory Submissions: Prepared and submitted regulatory documents to IRBs/IECs and Health Authorities for study approvals
• Ensured site readiness by coordinating instruments, ancillary materials, IMP/NIMP, and essential software systems including PRMS, IPMS, EDC, e-TMF, PDMS, and MI-LP.

# Operational Management:

• Reviewed protocols for operational feasibility and provided expert input to support successful trial execution.
• Led development of study plans, defining objectives, methodologies, and endpoints to enhance trial clarity and focus.
• Drove study execution using performance metrics and quality indicators; contributed to data review, protocol deviations, and patient tracking.

#Budget Management

• Managed trial budgeting by estimating costs, incorporating contingencies, and aligning with finance and procurement for smooth approvals.
• Negotiated and finalized PI grants with defined scopes, responsibilities, and reporting structures; monitored unit budgets to meet spend rate, funding, and cost-saving targets.

#Collaboration with Cross-Functional Teams:

• Streamlined data management for efficient analysis and reporting of clinical study results.
• Coordinated QA, medical monitor, and sponsor site visits across trial phases to ensure quality oversight and effective CAPA implementation.
• Managed sponsor communications through monthly updates to ensure alignment and transparency throughout the trial.
• Collaborated with medical experts, investigators, and external partners to ensure accurate data collection aligned with research objectives.

#Clinical Operations:

• Auditing quality systems in clinical, analytical, Pharmacokinetics & statistical through system audit (IT, PKBS), Clinical facility & process/project-based audits to confirm GCP, GLP, and other pertinent regulatory compliance by doing in-process /retrospective audits.
• Preparation of audit summary reports, categorization of findings, and reporting of audit outcome report with respective teams/departments for initiating, allocating, follow up on action points/CAPA plans/Deviations/incidents till closure.
• Involvement in Protocol review (Draft/Approved Protocol, ICFs, CRFs, and source data) and providing inputs to study design.
• Retrospective audit of study data electronic Instrument generated data, applicable e-CTD module, summary report & CSR / study report / e-TMF, PK report/tables and statistical analysis plan and/or amendment/addendum/erratum applicable regulatory specific tables/ annexure/documents.
• Audit of Pharmacokinetic & Biostatistics Phase (Decoding of data) of study.

#Building an effective Quality Management System:

• Preparation and review of QA SOPs, General SOPs, MSOPs, manuals, and policies.
• Suggesting, managing, and tracking Deviation (system/protocol/SOPs), CAPA, and change control are adequate & to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and best practices.
• Presenting Monthly Report to management (RTM) which summarizes inspections, deficiencies & updates related to Quality System preparation.
• Manage and update the site master file (SMF).
• Supported archival processes by ensuring accurate document management and immediate accessibility for audits and reviews.
• Conducted thorough review and verification of Qualification, Validation, and Calibration documents, including user privileges and audit trails for instruments and software (e.g., DPCM, SAS, Analyst, MassLynx) utilized across clinical, pharmacokinetics, and statistical divisions.

#Training and Development:

• Led implementation of Learning Management System (LMS) software to streamline training and development processes; served as primary training coordinator, overseeing program design, scheduling, and compliance tracking.
• Served as Lead Training Coordinator, responsible for planning, executing, and evaluating training programs aligned with current systems, organizational guidelines, and regulatory requirements for both new hires and existing staff

#Analytical Instrument Handling:

• Proficient in operating LC-MS/MS (API 3000/3500/4000, Waters Xevo TQS), UPLC, HPLC, solid-phase extractors, centrifuges, and nitrogen evaporators.
• Developed and validated bioanalytical methods for quantifying drugs and metabolites using diverse extraction techniques.
• Performed bioanalysis of study samples and prepared preliminary BA/BE study reports; calibrated analytical instruments to ensure accuracy and compliance.

#Project Trainee:

• Reviewed clinical documents (protocols, case reports, informed consent forms, updates, and deviations) and provided expert input to ensure clarity and compliance..
• Facilitated effective communication to ensure timely resolution of queries across teams and stakeholders.
• Reviewed clinical protocols and final study reports, offering strategic input on study design and methodology.
• Maintained regulatory compliance for all projects.