SHANKER KRISHNAMOORTHY

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OBJECTIVE:

A certified Clinical Research professional seeking opportunity in the area of Clinical Research to utilize my Technical and Managerial skills to deliver creative solutions for the advancement of organization. PROFESSIONAL EXPERIENCE:

CLINICAL RESEARCH EXPERIENCE – 14 YEARS

Job Profile Duration Job Description Employer

Project Manager –

Clinical Operation

Aug 2019 – till date

Clinical Operations

Management and Line

Management

Invitro Research

Solutions Pvt. Ltd.,

Associate Manager -

Records Management

Apr 2017– Jun 2019 Line Management, Process and

Functional Management.

IQVIA Research India

PVt Ltd

Assistant Manager –

Records Management

Jan 2014 – Mar 2017

Line Management, Process and

Functional Management.

QuintilesIMS India Pvt

Ltd

Associate Manager - QA Jul 2012 – Dec 2013

Worked as internal QA and QC

for Clinical Research,

Regulatory Activities and Trial

Supply Management

Cytespace Research

Private Limited

Senior Monitor and QA

Associate

(Auditor/Monitor)

Oct 2009 – Jun 2012

Worked as internal QA & QC,

Regulatory person.

Translational Medicine

India Pvt. Ltd

Monitor and QA

Associate

(Auditor/Monitor)

Mar 2008 - Sep 2009

Translational Medicine

India Pvt. Ltd

Clinical Research

Coordinator (CRC)

Mar 2007 – Feb 2008 Worked on 2 Oncology, 1 POC,

1 Observational studies

Translational Medicine

India Inc

EDUCATIONAL QUALIFICATION:

Qualification Board/University Year of Passing

MSc.CR (MSc in Clinical Research) (ICRI) affiliated with Cranfield University, UK

Aug 2006 - Apr 2008

PGDPM (Post Graduate Diploma in

Pharmaceutical Management)

Institute of Clinical Research India

(ICRI)

Aug 2006 - Aug 2007

B. Pharmacy (Bachelor in Pharmacy) Dr. M.G.R. Medical University Aug 2001 - Aug 2005 D. Pharmacy (Diploma in Pharmacy) Dr. M.G.R. Medical University Apr 1998 - Apr 2000 ROLES AND RESPONSIBILITIES IN CLINICAL RESEARCH FIELD: Project Manager– Clinical Operation:

− Managed project level operational aspects of Clinical Trial Team (CTT) including; Management of trial timeline, compliance, allocation, budget, resources and vendors. SHANKER KRISHNAMOORTHY

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− Provided efficient updates on trial progress to the Department Head (DH) and/or Senior Management team, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.

− Lead and supported sponsor study startup process, including but not limited to conduct of the Trial Kick- off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

− Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

− Ensure potential study risks are escalated to the attention of the DH when appropriate.

− Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

− Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.

− Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.

− Reviewed and approve vendor invoices in collaboration with the CPM and Accounting team to ensure investigator payments occur in a timely manner.

− Reviewed and approved vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

− Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.

− Effectively provide support to CRAs and Clinical Site Team(s) in the conduct of the trials and Other duties as assigned.

− Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review and mentored training experiences, as applicable.

− Frequent Reviews QIP for own projects, identify and provide required technical and logistical support for quality improvement (if necessary)

− Defined and Created processes for various functions and created guidance documents for the same. Created process guidance documents for Quality Matrices. In Line Management:

− Managing teams of 12 employees (Project team and line reporting team)

− Working on monthly metrics analysis to ensure the employees utilization.

− Lead and support the team for continuous improvement initiatives.

− Manage staff in accordance with organization’s policies and applicable regulations, including:

− Planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems

− Monitoring and tracking the work allocations for effective employee utilization

− Ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity, delivery, quality and financial targets;

− Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.

− Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process (Conduct more than 50 technical interviews)

−

SHANKER KRISHNAMOORTHY

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Associate Manager & Assistant Manager – Records Management (Paper and electronic TMF):

− People Management and Project Management

− Planning, assigning and directing the team to complete the process on time with high quality.

− Ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity, delivery, quality and financial targets;

− Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff

− Managing teams which has more than 40 employees (functional team and line reporting team)

− Working on monthly metrics analysis to ensure the employees utilization

− Lead and support the team for continuous improvement initiatives

− Manage staff in accordance with organization’s policies and applicable regulations, including:

− Planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems

− Monitoring and tracking the work allocations for effective employee utilization

− Frequent Reviews QIP for own projects, identify and provide required technical and logistical support for quality improvement (if necessary)

− Defined and Created processes for various functions and created guidance documents for the same.

− Created process guidance documents for Quality Matrices.

− Conducted frequent internal quality checks and provided feed backs to the team to have a better quality of work without impacting the delivery.

− Conduct employee performance assessment and their appraisals

− Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process (Conduct more than 300 technical interviews)

− Onboard, train, and mentor staff assigned to them

− Conduct on boarding training for new staff in conjunction with Human Resources and Global Talent training programs

− Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review and mentored training experiences, as applicable

− Participate in the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training; organize staff including shift patterns and the number of staff required to meet demand

− Lead and support the team for continuous improvement initiatives

− Established systems and procedures to ensure quality for better improvement.

− Oversight manager for department’s facility supports (guide and support employees regarding their transport, IT, Floor and other facilities related issues and challenges in second level escalations) In Line Management:

− Managing teams which has more than 40 employees (functional team and line reporting team)

− Working on monthly metrics analysis to ensure the employees utilization

− Lead and support the team for continuous improvement initiatives

− Manage staff in accordance with organization’s policies and applicable regulations, including:

− Planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems

− Monitoring and tracking the work allocations for effective employee utilization SHANKER KRISHNAMOORTHY

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− Frequent Reviews QIP for own projects, identify and provide required technical and logistical support for quality improvement (if necessary)

− Ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity, delivery, quality and financial targets;

− Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff

Associate Manager - Quality Assurance:

In QA and QC

− Established systems and procedures to ensure cGMP and GCP compliance, Technical other requirements.

− Preparation, review and quality control of Essential Documents, Standard Operating Procedures (SOPs) for Clinical Operations, Trial Sites and Clinical Trial Supply Management.

− Conduct of multiple site Audits and In-house Audits for GCP compliance.

− Routine QC check of the Clinical Operations Department Activities and Clinical Trial Supply Department and its related activities.

− Maintain and update Quality Assurance System Documentation, Deviation Control, Change Control, etc.,

− Conduct of Vendor audit for Qualification and Process

− Involved in developing software for inventory management for Clinical Trial Supply Department.

− Participate in the strategic planning and implementation of Clinical Audit plan; manage Corrective And Preventive Action (CAPA) plans

− QA check and approval of clinical trial supplies before release, during receipt and after receipt of the materials.

In Regulatory

− Preparation, review and approval of Common Technical and essential documents before National and local Regulatory body’s submission.

− Follow-up with the ethics committees in obtaining clinical trial approval

− Work with the operational team to clarify or to provide response to the query(ies) raised by the National and local regulatory bodies as applicable

− Involved in Initial and follow-up submission of AE/ SAE/ Periodic Safety reporting to the National and local regulatory bodies

− Conduct of Trainings and provided consultation on regulations, guidelines, compliance status, and policies and procedures of the organization.

− Conducted Ethics Committee audits for the regulatory compliance.

− Worked on Ethics Committee registration process (Drafting EC SOPs and creation of registration dossiers for 7 Ethics Committee)

As Senior Monitor and Quality Assessment Associate (Monitoring & inhouse Auditor): As Monitor:

- Supported site in EC and Regulatory dossier preparation and submission.

- Conducted Site, Investigator and Ethics Committee Feasibility visits.

- Performed all the process from Site Initiation to Site Closeout visits for 3 studies. SHANKER KRISHNAMOORTHY

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- Conduct 47 monitoring visits to check compliance to GCP, study protocol, Standard Operating Procedures

(SOP), Source document verification (SDV) and other regulatory requirements,

- Ensuring proper storage, dispensation, and accountability for clinical trial supplies at study site.

- Tracking & indexing site-specific essential documents - creating site specific shadow files.

- Generate and resolve the queries in source and CRF.

- CRF retrieval and assisting the Data Management team in Data Validation.

- Study close out procedures involving CRF retrieval, archiving, and communications to Sponsor, IRB and DCGI, drug destruction.

- Data Validation and generation the DCFs.

-

As QA Associate:

− Conduct internal QA Audit visits like Investigational Site Audit, In-house Audit, Essential Documents Audit, Ethics Committee SOP Audit, Data Base Audit, Vender Audit, Trial Master File Audit and System Audit and Process for compliance. (GCP and SOP compliance audit and Process audit)

− Generating QA Audit report and communicating the observations with the study team.

− Generate the Audit report along with categorizing the findings within the given timelines.

− Preparation, review and approval of documents before National and local Regulatory body’s submission.

− Participate in the strategic planning and implementation of Clinical Audit plan; manage Corrective And Preventive Action (CAPA) plans.

− Coordinate action plan implementation and quality control from the observations made during the Quality Assessment visits.

− Provide consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.

− Preparation, review and quality control of Standard Operating Procedures (SOPs). Regulatory:

− Assist the project team with the preparation of regulatory submissions, follow-up for approvals.

− Review of essential document before regulatory submission and ethics committee submission.

− Directed the project team in AE/ SAE/ Periodic Safety reporting.

− Guided the teams in safety reporting and regulatory submissions.

− Prepared safety reports, study status reports, audit and other visit reports.

− Involved in designing of essential documents like protocol, Case Report Form, Informed Consent Document, Data Collection Form, Source Document and various logs with review.

− Preparing scientific responses to Regulatory and Ethics Committee queries.

− Communication follow-up with Regulatory and Ethics Committee to provide clarifications, Interim study status submission, report submission, Serious Adverse Event notification.

− Provide support to the Project Team through documentation review, maintenance, and tracking. review of study files periodically for accuracy and completeness

− Provide team with a list of pending essential documents prior to site visits, to ensure that documentation is maintained as complete and accurate throughout the clinical trial. ICH GCP Training and Technical Induction:

− Conducting Technical Induction for New employees SHANKER KRISHNAMOORTHY

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− Provide training on GCP and other required clinical research topics to staffs, educating and evaluating their knowledge by conducting tests

− Involved in organizing the Investigator Meeting for Device study, Bio-similar study, Narcotic Drug Clinical Trials

− Participated and Conducted in couple of Investigator Meetings. Clinical Research Coordinator:

− Assisted in designing documents like ICD, CRFs other study logs (Like: Subject Screening Logs, CRF Inventory Log, CT scan Inventory Log, Drug Accountability Log, etc.,)

− Assisted in ICF administration process and Subject recruitment process

− CRF Annotation, CRF Checking & CRF Retrieval

− Assisting for Regulatory Submissions & Ethics Committee Submissions.

− Communication with the Institutional Review Board

− Maintenance and updating of Site Master File

− Data Query Generation, Drafting of Guidance Documents

− Serious Adverse Event – Reporting to Sponsor, IRB

− Involved in the process of archival of study documents after the study completion.

− Assisted in Drug Destruction process

Experience in Handling Electronic Data Capture System:

− Involved in the development software platform for designing EDCS.

− Trained in handling electronic-Case Report Form (e-CRF) Follow up with site staff during the internal QA monitoring visits to ensure the data from patient clinical notes has been transcribed into e-CRF in timely manner/based on study visits.

− Data Entry Operator

− Learnt the process of data validation from Double-Data Entry

− Raised queries through Data Clarification Form and interfaced with appropriate person to bring them to resolution.

PROJECTS WORKED AND WORKING ON:

INTERNAL AUDITS AND MONITORING:

27 Internal Audits (GCP Compliance Audits, Site Audits, System Audit, Data Base Audit, Essential Document Audit, In-house Audit and Vendor Feasibility Audit)

47 Monitoring

3 Ethics Committee Audits

ACHIEVEMENTS:

− Developed Process Guidance documents, Quality, Productivity and Delivery Matrices for different processes

− Established Quality Management and Control Process

− Created 350 plus SOPs for Organization, Trial Sites, Trial Supply Department and lab Data Review.

− Created, Project Management Plan for the projects, QA Manual for the organization and for its individual departments.

− Created Business Continuity Plan for the Organizations SHANKER KRISHNAMOORTHY

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− Established systems and procedures to ensure GCP and cGMP compliance, Technical and other requirements.

− Established QC system of the Medical Data Review process CERTIFICATIONS:

Online GCP Training in ICH – GCP (2015 to 2020)

Six Sigma in Quality Management (2015)

Oracle RDC training (2014)

Inform 4.6 and 5.5 training (2014)

RAVE Training (2014)

Infosario training (2014)

Online GCP Training in ICH – GCP (2013)

Certification on warehouse software (PALMS) user training (2013) Certification in PharmaXM Online GCP Training (2012) Online GCP Training in ICH – GCP (2011)

Certification in Data Entry Operator in Electronic Information Capture Module (2010) Certification in PharmaXM Online GCP Training (2010) Certification in Corrective and Preventive Action Procedure (CAPA) Procedures (2010) Certification in Regulatory Process for Clinical Investigators (2010) DIA Certification in Pharmacovigilance and Risk Management (2010) E-Certification in Clinical Trial Software (2009)

Six Sigma in Clinical Research (2009)

National Conference of Biotechnology and Clinical Research (2008) PERSONAL DOSSIER:

Date of Birth: 15.04.1977

Marital Status: Married

Languages Known: English, Tamil, Kannada, Telugu, Malayalam and Hindi Current Address: Flat No: 44, 5th Floor, Goodwill Ganga Apartment, Binny Mills Employee Colony, Opp to Chandra layout Post office, Chandra layout, Vijayanagar, Bangalore-560040

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