Vairamuthu Ammaiyappan Email & Phone Number

Bengaluru, Karnataka, India

Responsible for Global Business Development in Clinical Research Space.

Bengaluru, Karnataka, India

Bangalore

Hyderabad Area, India

Bangalore

 Recruit, manage and lead the staff for performing Report Programming activities with in Data Management Group. Ensure the team is adequately trained in ICON and client trainings and adhere to all appropriate SOPs, policies and applicable regulations and guidelines. Make FTE assignments in conjunction with client team. Ensure staff meets expected study timelines and deliverables for programming activities. Evaluate performance and identify process improvement areas. Act as a point of contact for client manager. Carry out appraisal for the staff Manage issue escalations. Career management for the staff. Implement reward and recognition programs Attend relevant teleconference with the client management team. Prepare and assess team performance which includes productivity, utilization and efficiency. Validation of Timesheets completed by the associates and prepare spotfire reports for analysis. Screening of candidates and conduct Interviews for potential recruitment. Lead Team Meetings, Knowledge Sharing sessions and SME meetings.

Mumbai

 Have established clinical data review process, by creating various documents including Clinical Data Review Plan, Role descriptions, SWIs and process maps, Spotfire Specification documents, Communication log, etc. Responsible to drive the process, meet target SLA’s and act as a key contact for stake holders. To develop Spotfire visualizations and provide domain expertise to the clinical programmers to create visualizations. Perform clinical data review on ongoing basis helping the studies to achieve data base lock faster and preventing databases unlocks Responsible for Trend analysis of aggregate study data Communicate the clinical findings, trends and outliers to various stake holders during the clinical data review and follow up for resolution Responsible for generating various study reports to assess study trends and provide metrics for various stake holders Lead weekly and monthly client and team meetings  Setting goals and expectations, conduct performance review, assess productivity and utilization Tru time tracking and appraisal management for team members Conduct Interviews in recruitment drives and interview process  Provide guidance and support for team to achieve operational excellence Identify developmental areas for the team and encourage them to attend required training programme to improvise their skills helping them in career growth

Bangalore

•Review and monitor(Centralized Monitoring Model) reported trial data is medically congruent and acceptable.•Attend Kick-Off meetings and client meetings.

Identification of Potential Investigators for research association.Business Development.Setting up research facilities for associated sites as per regulatory requirements.Overseeing conduct of trials in associated sites.

Bangalore

•Coordinating all study start up activities of all the studies.•Timely submission of Feasibility to the CRO and Sponsor.•Preparing and updating site Standard Operating Procedure, training and implementation verification with the study team.•Selection of the team members•Planning strategies for the patient recruitment•Facilitating Monitoring Visits and Audits in the site.•Overlooking entire process of study conduct.•Updating Trial Master File and review of all Trial Master Files and Subject Study files.•Internal Monitoring and Audit of all ongoing trial includes verification of source documents, assessing inclusion and exclusion criteria, past medical records for eligibility and data entered in to the eCRF.•Ethics Committee coordination.•Review of Sponsor Monitoring visit reports for all the studies and to follow up till resolved.•Drug Storage maintenance and accountability. •Preparing study specific logs, trackers. •Setting up a new clinical research facility as per regulatory requirements.

M.Sc, Biotechnology

B.Sc, Biochemistry

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