DIVYA JASWAL

•Assist in the planning and start-up activities associated with the implementation of new clinical studies
•Draft and review reports related to clinical study laboratory manuals, analytical protocols and study reports
•Preparation of Data transfer agreement, Data transfer, Data reconciliation
•Generating monthly invoices to clients
•Liaise and coordinate with colleagues, partner organisations and client representatives to ensure activities are aligned to deliver goals
•Contribute to clinical project and team meetings as appropriate to aid with project tracking and reporting
•Coordinate and actively participate in company meetings including project and client management
•Compile and review reports on clinical activities, timelines and outcomes
•Maintain records to levels consistent with relevant standards
•Assist in the production of both internal reports and reports for clients

• Coordinate Project initiation activity, kick off meeting & scheduling of project telecommunications, once a project is confirmed from Business team
• Supervised a cross-functional team to deliver synthetic, medicinal chemistry projects within budget
• Coordinated with cross-functional teams to resolve project issues and mitigate risks
• Cross departmental functioning for project work across different R&D sites
• Project timeline tracking for timely deliverables & timely raising to senior team mates for issues/concerns
• Effective communication in discussion with technical team & senior team mates with external and internal stake holders (SCM, logistics, technical, QC, IPR, BD) for project needs
• Documenting relevant points with client & internal stakeholders for process adherence & audit record keeping.

• Develop, coordinate, and implement marketing plans to maintain and increase existing business, capture new opportunities & establishing initial business communication
• Hosting visits and meetings, develop presentation, support new clients with regard to CRO services (Conducting feasibility check)
• Preparation of site agreements, MSA, Contracts, Agreements and CDAs, budget and financial/site payment tracking during study conduct
• From product feasibility analysis, managing execution of pilot and pivotal bioequivalence studies, interpreting pharmacokinetic & statistical bioequivalence results to clinical study report submission
• Overseeing project operations and functions such as planning, design and development of project protocols, regulatory submission, data acquisition and management, analysis and reporting of study results, management of supplies and resources in adherence with the project timelines, budgets and quality standards.

• Requirement gathering from clients
• Involved in strategic planning for the future scope of progress and development in the field of pharmacovigilance
• Keeping up breast of Regulatory guidelines (such as ICH E2B (R3), GDPR) know-how and its applicability in pharmacovigilance solution
• Giving value-addition training to new and existing clients for enhancements/upgrades/Change Requests
• Product implementation & ongoing support
• Assisting team in interpretation and correct application of norms
• Validation of specific documentation such as IQ, OQ and PQ for regulatory solutions
• Participated and Documented internal/External audits and other quality assurance activities
• Support operations in providing root cause, CAPA closures and change control process
• Ensured consistent adherence to quality and compliance procedures, meeting internal and external requirements
• Developed and executed corrective action plans as needed, mentoring employees to properly execute such plans.

• Maintaining Communication with sponsors and internal departments & submission to Ethics committee for approval of the protocols, ICF and its updates, other study related documents, Study Updates
• Preparation, compilation and reviewing of Case Report Form, TMF and Source document verification, check in, Dosing and check out procedures
• Prepare, maintain and updating all the systems and SOPs in the department
• Conducting and compiling training evaluations and producing monthly training reports
• Provide Training to study personnel on GCP, SOP, Protocol, CRF and Study related activities.

• Managing the Clinical Data process for multiple simple or complex trials
• Acquisition of data from internet, Case Report Forms (CRFs) & Data Clarification Forms (DCFs)
• Collect & analyze the information about marketed & development stage products of Pharmaceutical companies
• Handle analytic queries of client related to clinical trials
• Construct records for clinical trials conducted all over the world
• Cover a wide variety of public & proprietary data bases: FDA, EMEA, NCI, CTRI, UMIN, PubMed for trial related information
• Data Analysis, Data Mining & Secondary Research
• Competitive scientific meetings and literature (PubMed) coverage
• Worked in Oncology, Cardiology, CNS team.