Helen Sathya Ponniah
Sr. Site ID Specialist
Chennai
Overview
15
15
years of professional experience
Work History
Sr. Site ID Specialist
Fortrea
03.2022 - Current
- Ownership of the Feasibility/Site identification tasks in designated lead studies inclusive of but not limited to maintaining the site ID tools, running inconsistency checks.
- Provide support to Site selection lead for an oversight study by maintaining the site ID tools, CDA review, running inconsistency checks.
- Archiving emails at regular intervals and extract bulk PDF using company software as previously agreed.
- Provide support to Site selection lead in their assigned tasks of site list development by performing inspection checks, past experience checks, Canada Opt in/out, Citeline data.
- Working with other Site Specialist and External Vendors as a part of PI Contact task force.
- Deduping Site list, SDL, Multiple PI affiliations etc.
- Ensuring timely delivery of all time sensitive tasks assigned for the PI task force team.
- Formerly Labcorp
Sr. Site ID Specialist
Fortrea
03.2022 - Current
- Ownership of the Feasibility/Site identification tasks in designated lead studies inclusive of but not limited to maintaining the site ID tools, running inconsistency checks.
- Provide support to Site selection lead for an oversight study by maintaining the site ID tools, CDA review, running inconsistency checks.
- Archiving emails at regular intervals and extract bulk PDF using company software as previously agreed.
- Provide support to Site selection lead in their assigned tasks of site list development by performing inspection checks, past experience checks, Canada Opt in/out, Citeline data.
- Working with other Site Specialist and External Vendors as a part of PI Contact task force.
- Deduping Site list, SDL, Multiple PI affiliations etc.
- Ensuring timely delivery of all time sensitive tasks assigned for the PI task force team.
- Formerly Labcorp
Sr. Analyst, Feasibility
ICON Plc
03.2020 - 02.2022
- Setting up survey and communication templates; facilitate registration of principal investigators and adding them to appropriate surveys.
- Creation of Feasibility Questionnaires and dashboard set up.
- Training and Development of new Resources.
- Contribute in management of Central Investigator Database.
- Qualtrics and iSPRINT reports Analysis.
- Generating and customizing reports; sending eFQ/ CDA to sites; updating iSPRINT site status.
Sr. Analyst, Feasibility
ICON Plc
03.2020 - 02.2022
- Setting up survey and communication templates; facilitate registration of principal investigators and adding them to appropriate surveys.
- Creation of Feasibility Questionnaires and dashboard set up.
- Training and Development of new Resources.
- Contribute in management of Central Investigator Database.
- Qualtrics and iSPRINT reports Analysis.
- Generating and customizing reports; sending eFQ/ CDA to sites; updating iSPRINT site status.
Analyst, Feasibility
ICON Plc
03.2013 - 02.2020
- Adding investigators to surveys, Survey Status updates, Cloning of Communication Templates, Sending Feasibility Questionnaires/ Confidentiality Agreements electronically, Update Clicktools data in iSPRINT (Data Validation).
- Registration of sites & Investigators, Updating data to the existing records in Master Data Hub.
- Data Management: Clicktools & iSPRINT. undertake other reasonably related duties as may be assigned from time to time.
- Providing feasibility support to project teams and act as back-up when necessary.
- To document and report on lessons learnt.
- Actively participate in administrative projects and initiatives as assigned, being able to make sound decisions based on available information in order to contribute to the success of the group and ICON.
- Be able to network and collaborate with other professionals, attending and presenting at meetings both internally and externally.
- Maintenance of e-room (pdf prints, CRT tracker), updations in eRoom.
- Data Analysis: Creation of Feasibility Questionnaires, adding logics, extraction and analysis of excel & pdf reports.
Analyst, Feasibility
ICON Plc
03.2013 - 02.2020
- Adding investigators to surveys, Survey Status updates, Cloning of Communication Templates, Sending Feasibility Questionnaires/ Confidentiality Agreements electronically, Update Clicktools data in iSPRINT (Data Validation).
- Registration of sites & Investigators, Updating data to the existing records in Master Data Hub.
- Data Management: Clicktools & iSPRINT. undertake other reasonably related duties as may be assigned from time to time.
- Providing feasibility support to project teams and act as back-up when necessary.
- To document and report on lessons learnt.
- Actively participate in administrative projects and initiatives as assigned, being able to make sound decisions based on available information in order to contribute to the success of the group and ICON.
- Be able to network and collaborate with other professionals, attending and presenting at meetings both internally and externally.
- Maintenance of e-room (pdf prints, CRT tracker), updations in eRoom.
- Data Analysis: Creation of Feasibility Questionnaires, adding logics, extraction and analysis of excel & pdf reports.
Clinical Trial Assistant
ICON Plc
09.2011 - 02.2013
- Understanding the Clinical Trial Agreements, Data entering the rates.
- Ensuring the Bank details.
- Maintenance of contracts in Local drive by copying them from eRoom as and when it is uploaded.
- Responsible for allocating FTEs and giving authorization for the requests.
- Updating Planview Attributes for various studies for the requests received from Project Managers.
- Ensuring compliance by generating reports for Data Entry Cycle time and Query Cycle time Reports for sites.
- Facilitating Investigator payments by generating site specific reports for Enrollment activity and Visit configuration.
- Ensure escalation of site issues mentioned in Monitoring visit reports.
- Clinical Trial Assistant responsible for maintaining the Clinical trial management systems up to date.
- Maintaining Inventories of study members.
Clinical Trial Assistant
ICON Plc
09.2011 - 02.2013
- Understanding the Clinical Trial Agreements, Data entering the rates.
- Ensuring the Bank details.
- Maintenance of contracts in Local drive by copying them from eRoom as and when it is uploaded.
- Responsible for allocating FTEs and giving authorization for the requests.
- Updating Planview Attributes for various studies for the requests received from Project Managers.
- Ensuring compliance by generating reports for Data Entry Cycle time and Query Cycle time Reports for sites.
- Facilitating Investigator payments by generating site specific reports for Enrollment activity and Visit configuration.
- Ensure escalation of site issues mentioned in Monitoring visit reports.
- Clinical Trial Assistant responsible for maintaining the Clinical trial management systems up to date.
- Maintaining Inventories of study members.
Clinical Research Coordinator
Consortium Clinical Research India Pvt ltd
10.2010 - 08.2011
- Study Coordinator responsible for the conduct of clinical trials in compliance with applicable regulatory requirements, Study Protocol and Company SOPs at 3 different sites.
- Maintenance of Database of 4 different sites.
- Contact Investigators and freezed sites to conduct study.
- Assisted in the preparation of study protocols and ICD.
Clinical Research Coordinator
Consortium Clinical Research India Pvt ltd
10.2010 - 08.2011
- Study Coordinator responsible for the conduct of clinical trials in compliance with applicable regulatory requirements, Study Protocol and Company SOPs at 3 different sites.
- Maintenance of Database of 4 different sites.
- Contact Investigators and freezed sites to conduct study.
- Assisted in the preparation of study protocols and ICD.
Education
Diploma - PG Diploma in Clinical Research
Consortium Clinical research India Pvt ltd
Coimbatore, Tamil NaduBachelor of Technology - B.Tech
Karunya University
Coimbatore, Tamil NaduOther
Not Applicable
Therapeutic Experience
- Ophthalmology, A four week randomized multicenter, double-blind, two-treatment, multiple dose, single-period, Parallel Study for evaluating pharmacodynamics equivalence of XXXX and XXXX in patients with ocular hypertension or open-angle Glaucoma., Contact Investigators and freezed sites to conduct study., Assisted in the preparation of study protocols and ICD.
- Oncology, A Phase 1, Open Label, Non- Randomized, Multi-Arm, Multi-Centre, Parallel Sequence Study to Determine the Maximum Tolerated Dose and the Dose Limiting Toxicity of XXXX in Relapsed Solid Tumour Cancer Patients., Maintenance of Database of 4 different sites., Study Coordinator responsible for the conduct of clinical trials in compliance with applicable regulatory requirements, Study Protocol and Company SOP’s at 3 different sites.
- Nephrology, Post marketing Surveillance study evaluating the safety and tolerability of XXXX., Collection of Data from different sites, CRF filling and sending them to sponsors., AE’s and SAE’s reporting in timelines, Study Documentation, IP accountability and study specific procedures.
Systems Experience
- MS Office
- CIteline
- DQS
- Viper
- Illuminator
Language Capabilities
ILR 5 (Native or Bilingual), ILR 4 (Full Professional Prof), ILR 2 (Limited Working Prof)
Memberships Awards
Award won at previous organization as well won 4 ACE awards in a span of one year for Quality job done at Fortrea.
Timeline
Sr. Site ID Specialist
Fortrea
03.2022 - Current
Sr. Site ID Specialist
Fortrea
03.2022 - Current
Sr. Analyst, Feasibility
ICON Plc
03.2020 - 02.2022
Sr. Analyst, Feasibility
ICON Plc
03.2020 - 02.2022
Analyst, Feasibility
ICON Plc
03.2013 - 02.2020
Analyst, Feasibility
ICON Plc
03.2013 - 02.2020
Clinical Trial Assistant
ICON Plc
09.2011 - 02.2013
Clinical Trial Assistant
ICON Plc
09.2011 - 02.2013
Clinical Research Coordinator
Consortium Clinical Research India Pvt ltd
10.2010 - 08.2011
Clinical Research Coordinator
Consortium Clinical Research India Pvt ltd
10.2010 - 08.2011
Diploma - PG Diploma in Clinical Research
Consortium Clinical research India Pvt ltd
Bachelor of Technology - B.Tech
Karunya University