Amrapali Nikam

18 Years of experience in the Clinical Research Industry. Significant experience in Cardiology, Oncology and Renal Transplant trials. Specialist in Document Management, Records Management, e-Archival, eTMF & Wingspan management. Specialist in System Set up - Project System controller, QRPM PPM / RM and CTMS set up. Specialist in eTraining folders Maintenance and Technical issues with eTraining folders / user profile / documents maintenance.

Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.

• 06/2005 - 06/2007, Forbes Marshall Pvt. Ltd, Executive Administrator, Maintaining Registers, Filing, handling telephones, Acknowledging the Purchase orders in ERP system, Payment follow up, Purchase order follow up with the customer, Making travel arrangements, Hotel bookings, handling petty cash, making expense statements. Looking after the office stationary, payment of the admin staff, daily correspondence with the customers for updating the status of the order (updating the dispatch details to the customer), email correspondence with the customer and interoffice. Answering queries of the customer on telephone.
• 05/2003 - 05/2005, Supreme Hydro Engineering Pvt Ltd, Office Administrator, Email correspondence, arranging divers for the underwater jobs at offshore in India as well as abroad & negotiation of the divers payment. Explaining the type of job to the divers. Scanning and sending the CV’s of the divers to the customer. Maintaining registers, filing, handling petty cash, preparing vouchers, looking after the payment of the office boys and some of the admin staff. Handling telephones, arranging meetings & appointments. Actively participated in tender submission, preparing all the documents required to submit the Tender.
• 05/2001 - 05/2003, Digital Systems, Office Assistant, Handling telephone, drafting letters, maintaining registers, filing, petty cash, looking after the stocks (Material availability), placing order for the material, preparing challans & Invoices, preparing vouchers.

• Phase 3, Chronic Renal Anemia, Centralized Monitoring Lead, Implementation of specific process initiatives arising out of transformation/innovation/ process re-engineering programs. Act as clinical research subject matter expert for various initiatives. Supporting the creation of frameworks, collaterals, whitepapers and accelerators relevant to the areas of expertise. Collaborate with respective stakeholders, including operations teams, global teams, and other functional managers as appropriate. Collaborating with peer business process specialists and promoting cross functional synergies. Mentor projects/ initiatives on industry best practices. Process improvement initiatives – liaise with the Quintiles stakeholders and support teams to review and provide oversight. Competency development – Develop training content, deliver training and monitor the growth of the competency. Process development, process pilots and process transition of key business processes that will be transitioned and executed by the group. Develop and deploy competency assessments working with the Global training department. Work with the delivery team and provide functional support to the teams on an ongoing basis. Process Quality and audit initiatives - Identify impacted areas, provide root cause and implementation of corrective and preventive action. Develop templates, re-usable assets and best practices. Creation of business cases, proposals and presentations related to the relevant area of expertise. Review and sign off on project requirements, process flows, gaps, and design documents. Perform the User Acceptance Testing; ensure the quality of the deliverable is in line with what has been agreed in the project requirements. Work with Enablement group to test the platform perform user testing. Work with Quality management to develop the QM plan for the work stream.
• Phase 3, Renal Transplant, 11, 10, 65, Clin Trials Asst, Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of Files and study material. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Assist in training and orienting new staff. May act as a mentor for less experienced CTAs. Handling Finance independently with regular coordination with Sponsor and sites. May perform assigned administrative tasks to support team members with clinical trial execution.
• Phase 2, Renal Transplant, 11, 3, 27, Clin Trials Asst, Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of Files and study material. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Assist in training and orienting new staff. May act as a mentor for less experienced CTAs. Handling Finance independently with regular coordination with Sponsor and sites. May perform assigned administrative tasks to support team members with clinical trial execution.
• Phase 3, Atrial Fibrillation, 65, Clin Trials Asst, Reporting as CTA to the Global Project Manager and the role includes: Attending & Arranging Meeting, noting the minutes of the meeting. Responsible for processes of all the payments of the sites associated with the study. Running several reports from the systems and circulating to the team to update the study status. Following up with Study team members to ensure that the assigned activities are completed within the given timelines on behalf of PM. Any other project deliverable as required by the study.
• Phase 3, Cancer - Breast, 10, Clin Trials Asst, Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of Files and study material.

• Nephrology, Renal Transplant
• Oncology, Cancer - Breast
• Cardiovascular, Atrial Fibrillation
• Endocrinology, Kidney Disease

• Inform, 1-2
• EDC-Other, 1-2
• In-House Monitoring Experience, ≥2 Years
• Audits and/or Regulatory Inspection, Yes
• Collection and Review of Regulatory Packages, Yes
• Conducting CRA Training, Yes
• ICF/Study Document Development, Yes
• International Project Experience, Yes
• Investigator Meeting Attendance, Yes
• Liaising with Customer and/or External Vendors, Yes
• Line Management of Clinical Staff, Yes
• Management of International Clinical Team, Yes
• Query Resolution, Yes
• Reg Body and/or Ethics Comm Submissions, Yes
• Site Selection Visits, Yes
• Study Files Maintenance, Yes