Data Clinical Research

Curriculum Vitae

Name : FLEMY BABY

Contact No : 081********

E Mail : ***********@*****.***

Address : No.D-7,155,SFS 407, KHB Colony, 4th phase, Yelahanka New, Bangalore

To be associated with a CRO/Pharma industry that provides an opportunity for a challenging and rewarding career by applying my knowledge, skills and potential in this profession. I would also like to make positive contribution towards your organization while promoting team spirit and own professional growth.

Post graduate diploma in Clinical Research and Clinical Data Management, ICBIO Clinical

Research Pvt. Ltd, 2014 -2015

Graduation in Nursing (2012) from KG College of Nursing, Coimbatore

Knowledge of ICH GCP and awareness of local regulations regarding drug research

Comprehensive knowledge about US FDA regulations and Indian Regulations

Practical knowledge in Open Clinica

Complete knowledge of MedDRA

Practical knowledge in completing and submitting CRF as per protocol requirements

Bio availability and bio equivalence study and guidelines

Hands on experience in SAS(Statistical Analysis Software)

Good knowledge of Internet browsing, Microsoft Word, Microsoft Excel and Microsoft PowerPoint

Good knowledge of Ethics in Clinical Research

Good Communication Skills

Passion to work

Quick in adapting to any situation

Capable of interacting confidently and efficiently with people of all levels

Positive Attitude and Self Determined

Hard Working and Sincere

Good decision making and analytical skills

Good Leadership skills

Organization : ICBio Clinical Research Pvt Ltd

Duration : From 4-6-2014 till date

Role : Study Coordinator

Organization : Subash College of Nursing

Duration : 1 year

Role : Clinical Instructor

Assisting Investigators and performing in conducting Clinical trial by following related SOPs and Regulatory guidelines

Oversee clinical operations and maintaining the related documents accurately by collecting data and submitting to the sponsor

Analyzing and reporting Trial related information/data to sponsor and communicating between PI, CRA and Sponsor

Verifying if the source data/documents and other trial records are accurate, complete, and well maintained

Coordination and planning of budgets, people and time management

Clinical Operations

Clinical Data Management

Pharmacovigilance

Full Name : FLEMY BABY

Father’s Name : P.P Baby

Address : Periyil (H), Moolamcode (PO), Palakkad (DT), Pin: 678684, Kerala.

Date of Birth : 04-10-1990

Sex : Female

Nationality : India

Language Known : English, Malayalam, Hindi, Tamil, Kannada

Willingness to relocate : Yes

I hereby declare that the information given above is correct to best of my knowledge.

Date: 05-01-2015

Place: Bangalore FLEMY BABY

Contact this candidate