Vikas Nema Email & Phone Number

Mumbai, Mh, In

Mumbai, Mh, In

Sagar, Madhya Pradesh, India

1. Lead and manage the CRA team in the Asia Pacific (APAC) region.2. Liaises with internal groups as mentioned below to foster open communication related to strategy development, business planning and problem resolution.• Clinical Operations, including NLS affiliates.• Head of PM and related teams• Global Head Clinical Operations and related teams• Quality Assurance • Medical Services & Pharmacovigilance• Biometrical Services & Data Management• Clinical Technology infrastructure teams• Proposal & Business Development• Marketing & Contracts• Human Resources• Finance & Controlling• Vendors3. Liaises with external groups including industry associations and regulatory bodies to foster effective communication related to strategy development, business planning and problem resolution.4. Provide support to Clinical Operations/ PM group of NLS subcontractors, partners and vendors Project-related contacts of clients and sponsors5. To ensure implementation of ISO 27001 (Information Security Management System) requirement in compliance with relevant procedures.6. Provide input in Project review meetings (PRMs).7. Provide inputs on lessons learned and provide support to PM/CRAs.8. Mitigate team conflict and communication problems. Motivate team to work together in the most efficient manner.9. Lead the Global NLS-Clinical Operations SOP Harmonization process.

Sagar, Madhya Pradesh, India

Sagar, Madhya Pradesh, India

Bengaluru Area, India

Bengaluru Area, India

Hyderabad Area, India

-Utilize project management tools to plan, track, prioritize and communicate timelines and deliverables to the project team and client.-Resource planning and management: -Conducts study start up meetings (internal and external) -Performs scheduling of activities and deliverables.-Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables -Utilizes delegation skills to obtain maximum productivity -Assess project quality and risk -Facilitates preparation of critical documents -Manages Independent Review process as per the turnaround time -Able to address 21 CFR Part 11 guidance with respect to project -Maintains signed copies of all financial and study specific documentation per the SOP -Manage the study to contract, including proactive management of budget, pass-through costsand contract amendments.

Hyderabad Area, India

-Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables.-Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to GVK Bio SOPs and/or client guidelines-Recruit investigators -Negotiate study budgets with investigators-Obtain, review, and process regulatory and administrative documents from investigator sites-Coordinate and present at Investigator’s Meetings-Participate in proposal meetings with potential clients-Resolve issues, questions, and requests for additional study supply-Review clinical data in-house-Resolve queries of CRF data with study site personnel-Review tables and Listings generated from study data-Train and mentor CRAs on monitoring, internal procedures, and query resolution

Hyderabad, Telangana, India

Feasibility, Site Selection, EC Submission, Site Initiation, Site Monitoring, Site Closeout

Hyderabad, Telangana, India

Feasibility, Site Selection, EC Submission, Site Initiation, Site Monitoring, Site Closeout

Monitoring

Monitoring

Worked with Spectra Clinical Research Center (SMO) Indraprastha Apollo Hospital, Delhi as a Clinical Research Coordinator (CRC) in various Multinational, Multicentric clinical trials.

B. Pharm, Pharmacy

Education record