Trushali A. Mendre

Flat No-***, Mulani Plaza, Elphinstone Road, Bopodi, Pune, Maharashtra, India (Pin code of Pune:411003)

+91-986******* ~ ac3sth@r.postjobfree.com

Ready to relocate abroad, for medical writing opportunities.

Summary of Objective:

To be the best executor, for my organization & represent it at the best, in the competition with my logistics and skills.

Total experience: More than 6 years of Professional experience in Clinical Research (Roles: Disclosure Co-ordinator, Narrative Writer, Site feasibility manager}

Strength:

Confident, takes initiative, has Self drive & Self organization

Has good problem solving and good decision taking ability

Attention to detail

Ability to prioritize work in fast paced environment

Capable to work consistently till the set goal is achieved

Effective and proactive in communication with the authors, statistician, client and any vendors for completion of the project

Good writing skills using American Medical Association (AMA) guidelines

Proficient using Internet search engine & MS-Word, Excel, PDF editing & PowerPoint

Efficient in searching citations for references (PubMed, Clinical trials.gov, EudraCT)

Work Profile:

Currently working as a Disclosure Co-ordinator with TATA Consultancy Services (Senior associate Medical writer)

Narrative writer (Junior Analyst Medical writer) in Cognizant Technology Solutions Pvt Ltd. (Since Apr 2012 till 22 Sep 2015)

Worked as Clinical data manager for one year in Cognizant technology solutions.

Worked as a Site Feasibility Manger in Meliorate Clinical Research Pvt Ltd.{13th June till 31st March 2012}

{Initially joined as Clinical Research Co-ordinator (13th June) & then promoted to Manager Post from 1st August 2011}

Role as a Disclosure Co-ordinator:

Working for the client as a Disclosure Co-ordinator, where the role involves Posting result summaries on Clinical trials.gov using Protocol Registration system (PRS) and EUDRACT (European Clinical Trials database)

Drafting protocol summaries for CTg posting and EUDRACT posting adhering to the Style guide within stringent timelines.

Drafting the result summaries (with presentation of PK parameters and statistical interpretations).

Communicating with the Study team and the Statistician at various points to get the needful data if not available in the source.

Quality checks using quality checklist prepared internally for 100 per cent quality of the document.

Giving resolution, for the challenges being faced during the drafting stage of the study, specifically PRS and EudraCT.

Resolving the comments and concerns put forth by the regulatory authority (specifically NIH and EU comments on the drafts if any).

Therapeutic areas: Respiratory, Oncology, Infections, Dermatology, Cardiac, Neuroscience, Sample study (data presentation of samples rather than participants)

Underwent training on Clinical study report and assisted for writing, a non-interventional study report.

Currently has authored more than 200 clinical disclosures and Qced more than 250 disclosure documents, in refrence to standard checklist prepared as per the Final rule.

Role as a Narrative writer

Therapeutic experience: Oncology, Cardiology & Diabetes study.

Has worked on Oncology phase 2 and 3 studies. Written narratives for the same relatively AELD s, Death, SAE, and AESI along with presentation of lab parameters.

Has worked on a major Diabetology study and written Adjudication narratives (alongwith AESI, SAE, Death, AELD s etc)

Performed peer QC adhering to the quality checklist.

Performed Independent QC (IQC) for narratives

Handled Narrative tracking sheet to maintain the quantity and duration of the narratives.

Role as Site Feasibility Manager:

Taking meetings & keeping follow-up with Doctors from various Therapeutic Areas.

Doing site feasibility for Site development & standardization for trials.

Maintaining & updating the database of more than about 130 Investigators from various Therapeutic areas.

Making approach to CRO s for getting Projects related to varied Therapeutic areas.

Roles as Site CRC:

Patient recruitment & attending ICF process.

Arrangement for Patient visit viz, Kits, Calendar etc. IP storage & Accountability. Patient Safety & retention.

To keep all e-CRF S updated as per Source. (INFORM, Clinphone). Query resolution & DCF follow-up.

To evaluate all documents viz.ISF, Memos & Subject files before Monitoring visit.

EC submission of CIOMS, AE & SAE, Note to File, Protocol Deviation etc.

Academic Education:

Master s in Biotechnology, Fergusson College, Pune.,2010{Ist Class}

Bachelor s in Biotechnology,R.J.S.P.M. S College, Pune,2008{ Ist Class}

Professional Qualifications:

Has perceived a Certificate course in Clinical research (Basic & Advanced) from Jehangir Centre for Learning.

Documents worked :

Result and Protocol summaries for EudraCT and Clinical trials.Gov, Informed consent, Patient Narratives and Clinical study reports.

Underwent a basic training on Developmental Safety Update Report (DSUR)

Hobbies:

Reading scientific papers like MEDLINE, CIMS which covers the aspects of all updations in various fields {Cancer, Medications, Transplants etc.}

Surfing clinical research related & scientifically knowledge oriented sites

Talking to people & building a friendly atmosphere.

Reference:

1.Dr. Rupali Patil, Team lead, TCS (Mobile: +91-992*******)

2.Dr. Rakesh Pawar, All scripts, 823-***-****

3.Bhagyashri Sadavartr, Inventiv Andheri, 901*******

DECLARATION:

I hereby declare that all the above information given by me is true to the best of my knowledge & belief.

I would present all the documents at time of joining.

Place: Mumbai, India Initials:

Date: 13 Nov 17 T.A. Mendre

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