Project Manager Management

Avaani Manoj

Sawant

**** ******** **. ****. ***# 3A

Holland MI 49424.

About

Me A highly energetic professional with almost 6 years

of experience in diverse aspects of Clinical Data

Management. Currently pursuing course as QA analyst

Almost 6 years of experience in the field of

Clinical Data Management -

Good experience in Discrepancy Management using

Oracle Clinical 4.5.1 and OC RDC.

Designing study databases using Oracle Clinical

4.5.1 and InformRM.

Testing of clinical study databases.

Program and test validation procedures (Edit

Checks) in Oracle Clinical using SQL 4.5.1and in

InformRM

Designing CRFs.

Clinical Dictionary Coding in Oracle Clinical TMS

version 4.5.1

Good experience in Phase I to Phase III Clinical

trial studies using Oracle Clinical in various

therapeutic areas.

Knowledge of GCP.

Excellent communication and interpersonal skills,

good analytical skills and an attention to detail,

self-learning capabilities, people management

skills and flexible to work in a multi-dimensional

environment and on multiple activities.

Experience

Organization: SIRO Clinpharm Pvt. Ltd.

Designation: Data Management Project Manager and

Sr. Executive-Clinical Database Developer and

Editcheck Programer

Period: Nov2010 - July2012.

Key Responsibilities :

Complete overseeing of Startup, Conduct and

Closeout activities of given project.

Ensure internal departmental SOP and GCP/ICH

compliance and optimize general operation of the

department

Authoring and review of study related document DMP,

DVP and DE guidelines.

Accountable for ensuring project deliverables met

within clinical study timelines

Assisted in developing departmental SOPs and

training new hires in these documents.

Provide weekly and monthly project progress metrics

to the client.

Successfully and individually handled data

migration from clients database to inhouse

database.

Build clinical study database and write edit check

programs using SQL.

Organization: SIRO Clinpharm Pvt. Ltd.

Designation: Team Lead (SIRO-Pfizer Projects)

Period: Sep 2008 - Dec 2008

Key Responsibilities:

Lead a team of 6 dedicated resources in data

management activities using Oracle Clinical 4.5.1

Responsible for the quality of all deliverables

submitted by the team.

Introduce processes and improve existing processes

to ensure high quality outputs.

Training and mentoring team and resolving queries

from the team and customers.

Deriving study related metrics thereby tracking

efficiency of resources.

Optimize Resource Utilization and be responsible

for team's Appraisals.

Hands on data management activities as lead data

manger (LDM)

Organization: SIRO Clinpharm Pvt. Ltd.

Designation: Training Coordinator & Data Reviewer

Period: July 2008 to Sep 2008

Key Responsibilities:

Develop edit checks and data review of assigned

studies.

Ensure that all study start up activities are

conducted in compliance with relevant regulatory

requirements using agreed standards.

Drive and improve processes to minimize error

rates.

Implement and promote the use of consistent,

efficient and quality processes to meet timelines

and deliverables for the site based project teams,

be accountable for the quality and timelines of

deliverables.

Identifying training needs within the group, and

developing training modules.

Ensuring up-to-date documentation of training

records.

Providing training or orientation to the new

resources.

Perform random mock audit preparedness check on the

team.

Be compliant with all client procedures & SOPs.

Timely escalation of all issues to the supervisor.

To take on additional responsibilities proactively

as and when required.

Organization: Pfizer Pharmaceuticals India Pvt.

Ltd.

Designation: Associate Study Start up Analyst

Period: Feb 2006 -July 2008

Key Responsibilities

Develop database in Oracle Clinical 4.5.1 as per

the study/protocol

Provide technical expertise in the production and

delivery of the study start up services.

Be accountable for the quality and timelines of the

deliverables.

Ensure that all assigned activities are conducted

in compliance with relevant regulatory requirements

using agreed standards.

Participate where required, in implementation of

worldwide initiatives.

Creation of Global Library objects as per the

request

Provide support to Primary contacts (PCs) for study

start up issues as required.

Coding of medical terms using Clinical TMS version

4.5.1

Organization: Pfizer Pharmaceuticals India Pvt.

Ltd.

Designation: Associate Biometrician (Data Manager)

Period: March 2005 to Jan 2006

Key Responsibilities:

Prepare study documentation like validation

procedure specifications, Level-1 corrections

documents, CRF filling guidelines etc. for the

assigned study.

Test and execute validation procedures and database

Manage the discrepancies (auto generated and

manual) on the assigned studies in a timely and

efficient manner

Generate queries to clarify and improve the quality

of the data

Update data with query resolutions received from

the investigators and closing out the discrepancies

Provide feedback on the database designed for the

study by carrying out the database testing

Review of annotated Case Report Forms

Manual Review of the listings pulled from

Integrated Review and also quality control of the

data as seen on the CRF and the database

Liaise with external vendors and work in

coordination as a team to meet the timelines of the

study.

Perform the DB lock procedures as per the SOP

requirements

Perform database audit as part of Quality Control.

Run break blind/TDES.

Provide ad-hoc data listings as and when needed.

Education

Master of Science in Life Sciences specialization

in Biotechnology, 2004 with 65.30% (First Class)

from, Mumbai University, India.

Bachelor of Science in Life Sciences - 2002 with

73.00% (First Class) from Ramnarain Ruia College,

Mumbai University, India.

Certificate Course in Clinical Data Management

from Institute of Clinical Research India (ICRI)

Course in Quality assurance and software testing.

Computer

Knowledge Excellent proficiency in Oracle Clinical version

4.5.1 and Inform

Proficiency in Integrated Review version 9.1.1

Excellent proficiency in MS Word, Excel, Power

point, internet and other basic applications.

Personal

Information Gender: Female

Date Of Birth: 7th September 1981

Languages known: English, Hindi, Marathi.

Hobbies

Reading & Cooking

References

Ms Madhavi Pilankar

Sr Executive and Project Manager

Siro Clinpharm Pct Ltd

Email: *******.********@*************.***

Contact: +919*********

Ms Preti Soundatti

Sr Executive and Project Manager

Siro Clinpharm Pct Ltd

Email: *****.*********@*************.***

Contact: +919*********

Mrs Saswati Roy

Sr Manager-Clinical Data Manangement

Tata consultancy Services

Contact: +91-986*******

Mr. Purushottam Surti

Sr Manager-Clinical Data Management

Siro Clinpharm Pvt Ltd.

Contact: +91-981********

Contact this candidate