Clinical Research Security Gate

CAREER OBJECTIVE

SKILL’s

PROFESSIONAL EXPERIENCE

WORK EXPERIENCE

Sharad Suresh Gaikwad ************@*****.***

***, *** ********, **** **, Sec 26, Phase

**, ******, ***: Panvel.410208

Contact:987******* / C/O-998-***-****

16+ Years of experience in Bioequivalence as Project Coordinator, Team Leader of Screening

& Registration area and as QC (CQM-Clinical Quality Monitor). I am actively seeking a position in management and technical level allowing me to use my skills in the field of science and management to lend my expertise to an organization looking to grow.

• Masters of Science (MSc) – Chemistry [2020] from Singhania University.

• (PDCR)Professional Diploma in Clinical Research [2011] from Catalyst Clinical Services.

• (PGD)Post Graduate Diploma in Pharma Management [2008] from Mumbai University.

• Bachelors of Science (BSc) - Chemistry [2007] from Mumbai University.

• HSC [2003] from Mumbai-Board.

• SSC [1998] from Mumbai-Board.

• Faced 22 International Regulatory Inspections*.Facing Regulatory Inspection and Audit, Give compliance for the same (If any)

• 08 DCGI Inspections.

• Team Management.

• Preparation of Standards Operating Procedure (SOP).

• Good Clinical Practice (GCP) Project coordinator skills.

• Good Clinical Practice (GCP) Quality Monitoring skills.

• Document Management.

Working as Senior-Executive - Clinical in ENEM Nostrum Remedies Pvt. Ltd from Mar 2018 till date. Role and Responsibilities:

As CQM (Clinical Quality Monitor) – QC.

As Project Coordinator.

As Team Management and Lead of Screening and Registration Area.

As CQM (Clinical Quality Monitor) – QC (Current Profile)

Preparation and review of relevant SOPs

Planning of studies like conduction to dispatch of final report.

Monitoring of timescales and resources used to achieve Project Timeline.

Single of point of contact between Software (used in clinical) service provider and clinical department.

Hands on experience in conducting weekly meeting with Team members to discuss project status.

Keep update to Project management department for progress of studies.

Review of the documents (Protocol’s, ICF’s and CRF’s) required for submission to ethics committee and other documents to support clinical study.

Communicate with project management team in order to prioritize the assigned projects.

Communicate with quality assurance (QA) team in order to detect and resolve the issues on quality of the clinical documents ( Protocol’s,ICF’s and CRF’s)

Co-ordination with ethics committees for submission of final study protocol and other relevant documents for approval.

Communicate with Clinical research associate team regarding clinical study documents as and when required.

ACADEMIC DETAILS

Review screening activity, medical screening records and signed study informed consent form before commencement of clinical studies

Review the Trial Master file, Case record forms, Raw data for clinical study.

Ensure the completeness, correctness and compliance of data to protocol, SOP & applicable regulatory guidelines and documentation of deviations, if any

Ensure that all the study personnel are trained on the study protocol and duties are appropriately delegated, before initiation of any study related activities.

Monitor the following study specific activities/documents to ensure compliance to the protocol and the governing SOPs:

Urine/Breath Alcohol Test and Urine Screen for Drugs of Abuse

Pre-dose restrictions and Post-dose restrictions

Dosing (Ensuring blinding for blinded studies)

Biological sample collection

Vitals signs measurement

ECG (Electrocardiogram) monitoring (if applicable)

Clinical examination

Biological sample processing, separation, storage and transfer

Meal distribution

Adverse Event / Serious Adverse Event reporting, if any

Withdrawals, if any

Sample time point deviations

Clinical updates

Any other study specific requirements such as glucose test etc.

Ensure that necessary actions are taken for the observations/suggestions

Check the entire study related document i.e. MSR (Medical Screening Record), Raw Data, CRF etc.

Generate QC report.

Verify the compliance given by the delegated personnel.

Conducting BA/BE study on human subjects accordance with compliance of ICH GCP guideline and / or applicable regulatory requirements and standard operating procedure.

As Project Coordinator

To handle BA/BE Studies in Healthy Human Volunteers, as a Project Coordinator. Pre-study:

Review and finalization of ICF, CRF, and other appendices (applicable in case of special studies).

Preparation of Case Report Form (CRF) and/or associated working documents related to study and suggest any change to concern Clinical personnel.

Raising fund request for study.

Coordinate and interact with project management group.

Communication with sponsor / Independent Ethics Committee (IEC) / Institutional Review Board

(IRB) / Vendors regarding study.

Preparation, Maintenance and updating of Trial Master File (TMF) Prepare labels and Binders (binder, files, dispensing labels etc.).

Checking of Case Report Forms (CRFs) and Project Related Forms for its Completeness and do the Checked By.

Train the staff on SOPs related to concerned department.

Train the study personnel on project related activities and Distribute protocol and related documents to concerned person.

Ensure arrangement of staff and other study related activities.

Ensure proper initiation and conduct of the trial. During study:

Compliance of Subject before check-in

Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies.

To check completeness of inclusion/ exclusion criteria assessment and other tests to be conducted prior to study as per study protocol.

Accountability of ICF and Criteria checks.

Check all forms including consent forms.

Ensure arrangement for activities like, ambulatory, Pre-check-in visits, post study and co-ordination of the same.

Ensure subject contact during the washout period and follow-ups.

Reporting of SAEs, Adverse Events to the Sponsor, IEC and Regulatory Authorities.

Reviewing of training records of the staff

Ensure proper documentation of Adverse Drug Reactions, Note to files, Generate protocol / SOP deviations.

Ensure & Presentation of meal distribution, check in and checkout of subjects. Post study:

Handle subject compensation.

Follow up unresolved adverse events.

Compile and complete raw data.

Check all the forms.

Preparation of clinical updates & send clinical updates to all concerned.

Ensure timely release of project reports

Compilation and checking of case report forms, project related forms for its completeness

Send communications of discontinued subjects, BA details to concern.

Review of Clinical Study report.

Resolve to QA & Sponsor Queries, all Project Related Case.

Record Form in timely manner.

Raw data check for compliance as per SOP, Protocol and GCP etc.

Archiving and retrieving study related documents.

As Team Management and Lead of Screening and Registration Area

Handling regulatory Inspection and sponsor’s audits.

Handling of software like Online Volunteer Information System (OVIS) software, Volunteer Management System (VMS) software and contact service provider in case support.

Look after the screening procedures, managing staff duties and overall procedure.

Coordinating with clinical research team (PI/CI/PM) for planning of screening for upcoming projects.

Performing the Registration and Screening of the prospective Volunteer as per Screening SOPs.

Checking of all screening related documents (Registration form, Screening ICF, and Medical Screening Record) for completeness.

Coordinating with duty doctors, clinical investigator and principal investigator for volunteer’s fitness status who are eligible for the study.

Others

Handling of software Volunteer management System (VMS) software, Online Volunteer Information System Software (OVIS) activities

Carried out IQ, OQ and PQ of VMS and OVIS.

Review of System SOPs

Verification of Calibration records / Installation / Operational / Performance qualification of instruments.

Take part in the day-to-day conduct of the trials

Ensure timely conduct of clinical studies, Comply with GCP guidelines and SOPs

Handlings of Both Inter and Intra-Departmental Project Related Communication through Proper Channels.

Any Other Responsibility As Designated From Time To Time By The Head Of The Department / Designate.

Knowledge of ICH-GCP Principles & regulatory guidelines.

Successfully Regulatory Inspections faced-

US FDA- Feb 2019 and Feb 2023

ANVISA (Brazil)- 2022

MALAYSIA (NPRA)-2023

GCC-Gulf-2023

DCGI 2018, 2020 and 2022

Worked as Executive - Clinical in Alkem Laboratories Ltd from Jul 2016 to Mar 2018. Role and Responsibilities:

Handling regulatory Inspection and sponsor’s audits.

Conducting BA/BE study on human beings accordance with compliance of ICH GCP guideline and

/ or applicable regulatory requirements and standard operating procedure.

Look after the screening procedures and managing staff duties.

Coordinate with staff to smooth conduction of BA/BE study accordance with IEC approved Protocol. Compliance to CQA, QA and QC audit reports.

Handling of software like OVIS, VMS, ABS and contact service provider in case support. Preparation of SOP's.

Training to staff on SOP's

QC of study related documents.

Communicate with Path. Lab and X-Lab in case Discrepancy in reports.

Successfully faced inspections

US FDA- Aug 2016 and Dec 2018

WHO - 2017

UK MHRA-2017

China and Chile 2017

DCGI-2018

Worked as Executive - Clinical in Macleods Pharmaceutical Pvt. Ltd from Jun 2011 to Jun 2016 Role and Responsibilities:

Handling regulatory Inspection and sponsor’s audits.

Conducting BA/BE study on human beings accordance with the compliance of ICH GCP guideline and or applicable regulatory requirements and standard operating procedure.

Coordinate the clinical BA /BE studies. incharge of CPU unit.

Incharge of Screening and volunteer’s registration area.

Handling software like OVIS, Volunteers Database and Management. Coordinates the clinical BA/BE studies.

Carried out the clinical procedures like check-in, check-out, Meal distribution to the study subjects, ambulatory visits of volunteers. Sample separation, segregation and storage. Monitoring the study during its periods etc.

Preparation of SOP's.

Communicate with clinical team to smooth conduction of BA /BE Study. QC of related documents.

Successfully faced Inspections.

US FDA –Sep 2011, Mar-2013, Nov-2013, Nov 2015 and Apr 2016.

WHO-2014 and 2016.

UK MHRA-2014.

Thailand inspection-2016.

Australian inspection-2015.

DCGI – 2011, 2012 and 2014.

Worked as Executive - CRA Grade - 1 in Ashco Niulab industries Pvt. Ltd from Dec 2009 to Jun 2011 Role and Responsibilities:

Conducting BA/BE study on human beings accordance with the compliance of ICH GCP guideline and or applicable regulatory requirements and standard operating procedure.

Preparation of SOP's Coordinates the BA / BE studies.

Preparation of clinical update report during study reports. Preparation of Clinical Study Reports.

Communicate with smooth conduction of BA / BE Studies.

Successfully faced Regulatory Inspections

ANVISA

Turkey

Worked as CRA in Ace Biomed Pvt. Ltd from Oct 2008 to Dec 2009 Role and Responsibilities:

Coordinates the BA / BE Studies. Dosing to the subjects.

Obtaining study ICF.

FIELD OF INTERESTS

INDUSTRIAL EXPOSURE

ACHIEVEMENTS

CURRICULAR ACTIVITIES

REFERENCE

DECLARATION

Preparation of ICF, CRF and interim reports. Preparation of Clinical Study Report CSR as per E3 guideline.

Preparation of source documents. Monitoring the trial throughout its duration.

Centrifugation and Separation of plasma sample. Segregation of plasma sample.

Preparation of clinical update report during study periods. Preparation of clinical study reports.

QC of all study related documents. Successfully faced Sponsors Audits.

Successfully faced Inspections.

Turkey Inspection -2009

DCGI-2009

• Project Management in Clinical research-Drug Development processes and management.

• Computer handling, Managing staff, Handling team.

• ICH GCP and GLP Training in Enem Nostrum Remedies Pvt Ltd.

• ICH GCP Training in Alkem Laboratories Ltd and Macleods Pharma Pvt, Ltd

• An international conference on Contemporary Issue and future challenge in drug development held by South Asian Chapter of American College of Clinical Pharmacology [ACCP]

• Awarded for successfully facing US FDA Feb-2018 Inspection in Enem Nostrum Remedies Pvt Ltd.

• Participated to develop in-house Alkem Bioequivalence Software (ABS) a Volunteer Management and Information Software in Alkem Laboratories Ltd.

• Participated to develop in-house Volunteers Database (VB) Software in Macleods pharmaceutical Pvt Ltd.

• Participation certificate for volunteers for workshop on Biostatistics during graduation.

• Stood 1st in intra-college Antarang Antakshari in Std XI. Dr. Santosh Sacket

QM/QA Manager-Accenture Solutions Pvt Ltd.,

Chennai 935-***-****

Dr. Parag Pawar

Sr. Manager and principle investigator

Alkem Laboratories Ltd.

*****.*****@*****.*** 982*******

Dr. Bhupendra Mahadik

Ex- Sr. Manager-PI, Macleods Pharmaceutical pvt ltd. 982*******

All the information given in this document is true as per my knowledge. Place : Mumbai

(Sharad Suresh Gaikwad)

SKILLS

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