Nisha Rajendran

Head-cro Clinical Research (Including Regulatory Medical Writing, Cdm, Stat & Bioanalytical) @Amaris Clinical

Chennai, IN

Reviewing and Approving of Protocols, Informed Consent Documents, Case Report Forms, Study Reports, Regulatory Documents, SAS Programming, Clinical Data Management, CDISC, SDTM, ADaM, Regulatory Dossiers, SOPs of Clinical, Statistical and Bio-Analytical Phases.Overall In Charge of Clinical Research, Medical Writing, Regulatory Writing, Clinical Data Management, SAS Programming, Statistical Analysis, Bioanalytical, Pharmacovigilance and Quality Assurance.Plan, develop, implement and direct the organization’s operational and fiscal function and performance.Act as a strategic partner by developing and implementing the company’s plans and programs.Analyze and make recommendation on the impact of short term & long term growth initiatives, planning, and introduction of new strategies and regulatory actions.Develop credibility and authority for the finance leadership team by providing accurate analysis of budgets, reports and financial trends and operational procedures.Create, improve, implement and enforce policies and procedures of the organization that will improve operational and financial effectiveness of the company.Evaluate company’s financial, operational, and marketing structures to plan for continual improvements and a continual increase of operating efficiencies.Mentor and interact with members of staff at all levels to foster growth and encourage development among senior executive team and all members of staff.

Madras Medical College

M Pharmacy

Vels College Of Pharmacy

Bachelor of Pharmacy (B.Pharm.)