Akshay rajaram shanbhag

Permanent Address :

Golden Park Apartments,

Phase 4 – 304, Opp D-Mart,

Devarachikkanahalli main road,

Bangalore-560076.

E-Mail : ac8dci@r.postjobfree.com Phone : +91-828*******

Scaling new heights of success with hard work & dedication and leaving a mark of excellence on each step; targeting for Clinical Data Management assignments with a leading organization of repute in Healthcare industry

PROFILE SUMMARY

Knowledge on CDISC guidelines, International Conference of Harmonization / Good Clinical Practice(ICH GCP) guidelines and Clinical Trial Study Designs.

Dynamic career of 7 years that reflects expertise in Quality Assurance, Operations Management, Clinical data management and Training & Development

A forward thinking person with strong communication, analytical & organizational skills; well organized with a track record that shows self-motivation, creativity and initiative to achieve corporate & personal goals.

IT SKILLS

Applications: MS Office (Word, PowerPoint & Excel) and Internet Applications.

Database used: InForm, Medidata RAVE & OC/RDC.

ORGANISATIONAL EXPERIENCE SUMMARY

From Aug '17 Accenture solutions pvt ltd.,Bangalore as Medical Services Senior Analyst

June’16 to Jul'17 QuintilesIMS,Bangalore as Clinical Data Co-ordinator.

Apr’15 to May’16 Tata Consultancy Services Ltd., Mumbai as Senior Process Associate.

May’14 to Mar’15 Macleod’s Pharmaceuticals Ltd. Andheri (E), Mumbai as Senior Clinical Research Associate.

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Aug’11 to Oct’13 Macleod’s Pharmaceuticals Ltd. Andheri (E), Mumbai as Clinical Research Associate.

ORGANISATIONAL EXPERIENCE IN DETAIL

CURRENT EXPERIENCE

Company: Accenture Solutions Pvt Ltd.,

Designation: Medical Services Senior Analyst (Sr.Clinical Data Manager/CDR).

Duration: Aug 2017 to till date.

Therapeutic Area: Oncology.

Job Description:

• Managed delivery of projects through full data management process life-cycle.

• Provided comprehensive data management expertise (involved in preparation of Data Management Plan).

• Responsible for clinical data listings review at protocol level to ensure data submitted by investigative sites is of high quality and completed within predefined study timelines.

• As an SME (Subject Matter Expert), performed comprehensive quality control activities for respective studies.

• Worked in conjuction with PDM to develop new protocol specific data review tools, understand the analysisnand reporting needs of the protocol.

• Proactively collaborates with other study team members to address issues related to data quality.Effectively uses available tools and systems to gather information needed to manage clinical data listing review,generates reports, and provides feedback to the internal stake holders and DML.

• Performed SAE reconciliation and send out issues or query to Site and GPVE.

• Develop and maintain good communications and working relationships with CDM team.

• Interacted with CDM team members to negotiate timelines and responsibilities.

• Discrepancy Management, Performing Case Report Form (CRF) data review, raising manual queries and Query Management/ Query response updates to the Database according to the relevant guidelines.

• Provided process training amongst team members.

• Performed external vendor reconcillations such as ePRO and LAB.

• Performed SAE & IP reconcillations.

PREVIOUS EXPERIENCE

Company: QuintilesIMS (IQVIA).

Designation: Clinical Data Co-ordinator.

Duration: June 2016 to Jul 2017

Therapeutic Area: Oncology

Job Description:

• Managed delivery of projects through full data management process life-cycle.

• Provided comprehensive data management expertise (involved in preparation of Data Management Plan).

• Performed UAT (User Acceptance Testing), (Data base Informal Testing, Data Entry Screen, Enter the edit checks and testing).

• Performed comprehensive quality control procedures.

• Written edit checks specifications.

• Performed SAE reconciliation and send out issues or query to site.

• Designing of CRF in accordance with protocol and creation of CRF completion guidelines.

• Develop and maintain good communications and working relationships with CDM team.

• Interacted with CDM team members to negotiate timelines and responsibilities.

• Discrepancy Management, Performing Case Report Form (CRF) data review, raising manual queries and Query Management/ Query response updates to the Database according to the relevant guidelines.

• Provided process training amongst team members.

• Performed vendor reconcillations such as PK,ePRO’s and LAB.

PREVIOUS EXPERIENCE

Company: Tata Consultancy Services Ltd.

Designation: Senior Process Associate.

Duration: April 2015 to May 2016

Therapeutic Area: Respiratory

Job Description:

• Maintained full understanding of study documentation, including the protocol, in order to perform proper execution of data management activities.

• Performed discrepancy management in accordance with the Study Data Quality Plan and according to agreed upon timelines.

• Performed External Data reconciliation e.g. ECG, LAB, PK, PGx etc.

• Performed SAE & IP reconcillation .

• Point of contact to Monitors for data flow, discrepancy management and all other data management related processes.

• Tracked and followed missed CRF pages and outstanding discrepancies.

PREVIOUS EXPERIENCE

Company: Macleod’s Pharmaceuticals Ltd.

Designation: Senior Clinical Research Associate.

Duration: May 2014 to March 2015

Job Description:

• Preparation of protocols and its amendments, case record forms, informed consent forms.

• Reviews all IEC submissions /notifications, communication and facilitates prompt and correct completion by the Investigator.

• Checking and monitoring the online activity such as dosing, blood collection, vitals, check in, check out and ambulatory visit and online clinical documents during conduct of the study.

• Preparation of master file before initiation of study.

• Checking of pathology reports of pre study screening and post study screening.

• Preparation of clinical trial report (CTR) as per regulatory guidelines.

• Reporting of AE and SAE to Sponsor, Reporting to Principal Investigator, responsible for the efficiency of the workflow in study activities including CRF completion, query resolution, maintenance of trial related documents.

PREVIOUS EXPERIENCE

Company: Macleod’s Pharmaceuticals Ltd.

Designation: Clinical Research Associate.

Duration: August 2011 to October 2013.

Job Description:

• Ensuring safe and proper conduct of clinical study at trial site according to ICH GCP guidelines, research protocol and regulatory standards.

• Reporting of AE and SAE to Sponsor, Reporting to Principal Investigator, responsible for the efficiency of the workflow in study activities including CRF completion, query resolution, maintenance of trial related documents.

• Reviews all IEC submissions /notifications and facilitates prompt and correct completion by the Investigator.

• Monitoring of online activity during conduct of study.

• Managing research projects, its query resolution and deviation reporting.

• Preparation of Protocol, ICF’s and CRFs and clinical Trial report(CTR).

• Archiving study documentation and correspondence.

Internship

Company: Kilitch Drugs India.Ltd

Designation: Quality Assurance Inspector [QA] Intern

Duration: June 2010 to July 2011.

Job Description:

• All in process checks.

• Line clearance on every single stage from dispensing till the packing of the final sterile product.

• Final dispatch of the finished product.

• Preparation of BMR and BPR according to the SOP and regulatory guidelines.

TRAINING AND AUDIT

• Attended Investigators protocol meeting at Macleod’s Pharmaceuticals Ltd, Mumbai,andheri (E) and at SITEC labs PVT LTD Mahape,Navi Mumbai.

• Attended USFDA Audit, DCGI audit for facility audit,MHRA audit .

• Attended Workshop on Foundations OF Clinical Research and GCP training by academy for clinical excellence at CIPLA LTD.

• Attended Overview session on Resist(Cancer Lessions) at Tata Consultancy services Ltd.

Awards and recognitions

• Awardee of BRAVO and APLLAUSE at QuintilesIMS for Best Quality and Team work.

• Received high performance award at Accenture solutions Pvt Ltd.

ACADEMIC DETAILS

MSc in clinical research and regulatory affairs from Sikkim Manipal University (Corresponding) in 2015.

B.Pharmacy. from Sterling institute of Pharmacy, Mumbai University in 2010.

HSC from Modern College, State Board, Mumbai in 2006.

SSC from Modern School, State Board, Mumbai in 2004.

PERSONAL DETAILS

Date of Birth: 3rd June 1988

Languages Known: English, Hindi,Marathi,Kannada and Konkani(Macro language)

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