Ms. Gitika (Assistant Data Manager)

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Mobile: 987*******

Email: jch9uo@r.postjobfree.com

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Objective: Seeking a challenging career in the field of Clinical Research data management and wish to render my services for the position that utilize my skill & abilities in such a way that provide growth while being resourceful, innovative and flexible.

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CAREER SUMMARY

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Having more than two and half years of experience in CRO Industry. Good knowledge of project management, clinical research, database setup, statistics and documentation. Skilled in SAS based PheedIT and knowledge of Oracle Clinical (CDMS). Capable of adopting new technologies and new environment. A good team player with excellent interpersonal, logical, managerial and analytical skills. Delivered excellence in customer service through situation analysis and timely resolve of escalating problems.

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WORK EXPERIENCE

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Current Experience

Employer: Max Neeman International (ASIA) Ltd (From July 2008 till Feb 2011).

Job Title: Assist. Project Manager and Team Lead (Data Entry)

Key Roles and Responsibilities as

a) Assist. Project Manager

• Provide trainings of Protocol, Data Entry and Validation Guidelines to study Team Members.

• Preparation of Data Management Plan.

• Supervise and review different activities of study team to perform data management activities (Annotations, Database Design, Data Entry, Validation and Query Management, Quality Check of Database) for Paper based Trials to complete all activities of a project in given timelines and deliver an error free quality database in accordance with the Data Management Plan and ICH GCP Guidelines.

• To coordinate with Biostatistician and SAS Teams for the preparation of Statistical Analysis Plan and Statistical Analysis (Logic Flow).

• Generation of various reports of projects as per Sponsor requirements.

• Handling communication with sponsor independently for the assigned projects.

• Coordinate with Medical Report Writer during the preparation of Clinical Study Report.

• Work as per company SOPs and Client SOPs, if any, for a specific project.

• Knowledge of ICH-GCP Guidelines.

b) Team Lead – Data Entry

• Handling a team of 12 Data Entry Operators.

• Responsible for providing trainings to the team and help in recruiting new staff.

• Responsible for assisting and analyzing all the work of team members to meet organization’s objectives and goals.

• Provide Induction Training to the new joinees and regular training sessions for continuous training programme.

• To develop a team spirit within the team with the help of many team building exercises.

• Part of the team for yearly SOP revision and updation.

Previous Experience:

• Genpact India Ltd. Gurgaon as Senior Process Associate (From Nov 2005 till Jun 2008)

• Worked as a Senior Process Associate. The tasks and responsibilities delivered during this period are given below:

• Digitization of the medical records for the patients covered in medical insurance.

• Lead the communications team of COPC (Customer Operations Performance Center) audit for the entire process.

• Mentored 4 team members of the process.

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Worked with the team of 18 members of different projects in clinical data management.

Therapeutic areas Oncology, CVS, Endocrinology, Immunology, Neurology

Duration June 2008 - till date.

CDMS PheedIT (A SAS based software)

Team Size 18

Role Project Lead and Team Lead (Data Entry)

Organization Max Neeman International.

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ACADEMIC QUALIFICATION

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• M.B.A in International Business from Annamalai University, Tamil Nadu (2010)

• P. G. Diploma in Clinical Data Management from Institute of Clinical Research in India (ICRI), New Delhi in 2007.

• Bachelor’s Degree of Life Science from Sri Venkateshwara College, Delhi University (2005).

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SOFTWARE SKILLS

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• PheedIT, SAS based Clinical Data Management System, Version 3.0010

• Oracle Clinical Version 4.5.1

• MS-OFFICE

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ACHIEVEMENTS

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• Awarded Employee of the Month award for the successful and timely completion of a study.

• Received Star of the Month award twice as a recognition for project management skills demonstrated in two projects.

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PERSONAL DETAILS

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Name : Gitika

Father’s Name : Mr. Nand Kishor

Date of Birth : 27th May 1984

Address : H.No. 1552 Sector – 8 Faridabad.

Personal Email ID : jch9uo@r.postjobfree.com

Phone Number : +91-987*******

I hereby certify that the information provided above is true to the best of my knowledge.

Place: Faridabad (Gitika)

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