www.ppceworld.com PPCE World Pvt Ltd Pune : Clinical Data Base Manager

[mskavi]

PPCE Pune : Clinical Data Base Manager
Website: http://www.ppceworld.com
ppceworld.com

Designation: Clinical Data Base Manager
Experience: 10 - 12 Years
Location: Pune
Compensation:
We are willing to work on a package which will include salary and profit sharing. The essence of this business is meeting targets and building a brand image
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D

Job Description:
In its pursuit for diversification, PPCE is exploring the possibility of business development in Clinical Data Management.
We are seeking a professional with necessary years experience in this business having overall experience in business development, process control and various other nuances of clinical data management to head the division and develop the business.

Desired Candidate Profile:
The Candidate must be a team leader and have the capability of pursuing business development, setting and controlling systems and working to set targets. He effectively will be a profit centre head.

Company Profile:
PPCE is in the business of certification of quality standards. Its varied customer base and the different requirements of certification for each customer have resulted in its acquiring a strong experience in database management.

Email Address: fjdastoor@gmail.com

Keywords: Clinical Data Base Manager

[Guest-IJT]

Permanent Address:
Email:anamika1208@gmail.com House no-148,Sector-17
Faridabad (Haryana)
Mob-09911199530

CAREER OBJECTIVE
Seeking a challenging position where the knowledge I have gained can be utilized for development of organization. Aim is to maximize and enhance my skills in order to serve better the progress of the organization.

QUALIFICATION

DEGREE
BOARD/UNIV.
PERCENTAGE
M.PHARM(3rd SEM)
JAMIA HAMDARD,DELHI
78%
M.PHARM(2nd SEM)

JAMIA HAMDARD,DELHI
82%
M.PHARM(1st SEM)

JAMIA HAMDARD,DELHI
73.6%
B.PHARM

B.S.A.I.P (M.D.U)
76.5%
CLASS XII
MODERN VIDHYA NIKETAN SCHOOL,FARIDABAD
78.2%
CLASS X

MODERN VIDHYA NIKETAN SCHOOL,FARIDABAD
86.8%



M.PHARM RESEARCH PROJECT:
“Drug utilization pattern and adverse drug reaction monitoring of genitourinary tract infection in female patients.”

It is a prospective study which would be conducted at Majeedia Hospital, Delhi. It would help in determining the prevalence of the infections as well as would provide a comprehensive knowledge about the antibiotics used and the adverse drug reactions associated with them.
ACHEIVEMENTS
· Qualified GATE in 2007.

* Topped The College in All 4 Consecutive Years Of B.Pharm (2003-2007) and got scholarship throughout for the outstanding performance.
* Acknowledged As Meritorious Student By Indian Pharmacy Graduate’s Association (IPGA) in November, 2005
* Held University Ranks In 2nd Year (2nd Rank) and 4th Year (4th Rank).
* Topped in First Semester in Pharmacy practice securing 73.6%.
* Topped in Second Semester in University securing 82%.
* Awarded by Jamia Hamdard, Delhi for the outstanding performance in First yr (M.Pharm) in January,2009


TRAINING

* Clinical Exposure: Two years experience in different clinical settings. Worked as “trainee clinical pharmacist” on disease management, appropriate selection of therapy and drug-related problems. Underwent training at Medicine, Pediatrics, General Surgery ward of Majeedia Hospital,Delhi.
* Actively participated in organizing several workshop and conferences.

AREA OF INTEREST:

* Pharmacovigilance, Drug Regulatory Affairs and Clinical Research.

SEMINAR DELIVERED:

* Topics related to Pharmacovigilance.
* Scope of Clinical Research in India.
* Clinical Trials

SEMINAR ATTENDED:
· Mini symposium on “Data Safety Monitoring Board” organized by AIIMS, New Delhi on 15 September, 2007.
· Mini international symposium on “Drug, Discovery and Development” organized by AIIMS, New Delhi on 30 October, 2007.
· Indo-us symposium on “Novel Therapeutic Approaches for Management of Neurological Disorders”, organized by AIIMS, New Delhi on 19 November, 2007.


SKILLS AND EXPERTISE

* Excellent attention to detail and accuracy.
* Good research and communication skills.
* Can take responsibility for tasks and react to changing priorities.
* Have a good interpersonal skill and are able to work in a team or own if required.
* Knowledge of Clinical Research, Drug Safety, Pharmacovigilance, Regulatory authorities.
* Capability to make concise, accurate and relevant synopsis of medical text and data, and the ability to write unambiguous medical text.
* Ability to evaluate data and draw conclusions independently.


COMPUTER PROFICIENCY

* Proficient in Windows and application software: Windows XP, MS Office.
* Data retrieval from various internet portals like Science direct, Pubmed, Highwire press, Google scholar etc.


HOBBIES
Reading, Dancing And Listening Music
PERSONAL DETAILS:
· Father’s Name:Mr.O.P SHARMA
· Date of Birth:12/ August/1985
· Gender:Female
· Languages Known : English, Hindi (verbal and written)

DATE : (ANAMIKA SHARMA)

[Guest]

Arjun Sridharan
E-mail : arjunmadav AT hotmail.co.uk
arjunmadav AT gmail.com

Objective
Seeking a career in the field of CDM/SAS with almost 2 years of experience, where I can use and develop my knowledge and help in the growth of the organization.
Work Profile
Company name : Cognizant Technology Solutions (client: AstraZeneca)
Date : Feb 2010 to Present
Position : Clinical Data Manager (both study conduct and study setup)
Duties :
- Main Duties involve Discrepancy Management, Validation, UAT Testing, eCRF designing based on protocol specification, Creation of Visit Matrix, Data standards documents, Data validation specification (Writing of Standard edit checks/Field edit checks). Data Extraction specification, Data Management plan.
- Other duties Include identification of misfiring checks and highlighting this to the study setup unit.
- Tracking of pCRF pages with the scanning and indexing team, follow up with all the horizontal teams and provide updates to study team on a timely basis.
- Updating lab ranges in RAVE database as and when we receive it from the study team and follow up on any lab issues with the study set up team.

Studies/Therapeutic Area :
- Respiratory/COPD (Client : AstraZeneca)
o In-depth knowledge on Respiratory TA and worked on studies which involved more than 1800 subjects
o I had delivered more than 300 subjects in approximately 25 sites across the study with no QA and QC findings
o Complete knowledge on Manual checks, Consistency checks to be performed on Respiratory studies
o Some modules which I validated/Built : SUNIC, EXACD, EXACT, SGRQC, FPISF, INMARKB, INMARKS, INMARKU in Rave database
- Oncology (Client : AstraZeneca)
o Good knowledge on RECIST 1.1 Validation, writing Edit checks for the module.
o Worked on studies on 4 oncology studies which involve more that 400 subjects.
o Through knowledge on Manual checks and cross modules checks which involve in oncology studies.
o Some modules which I validated/Built : CAPRX, CAPRXR, BIOMARK. BIOPSY modules.

- Company name : Pfizer Limited:
- Date : October 2008 To May 2009
- Position : Professional service officer
o Arranging appointments with doctors, pharmacists and hospital medical teams, which may include pre-arranged appointments or regular 'cold' calling;
o Keeping up with the latest clinical data supplied by the company and interpreting, presenting and discussing this data with health professionals during presentations.
o Monitoring competitor activity and competitors' products.
o Making regular visits to Doctors and hospitals.
o Regularly attending company meetings, technical data presentations and briefings.
Academic Profile
- Post Graduate in Pharmaceutical : (2009)- Kingston University, London
- Bachelors in Pharmacy : (2008)- MGR Medical University
Additional Course/Skills :
- Clinical Data management (CDM) and SAS Training program :
Where in I gained a thorough knowledge on

- Clinical Trial, Clinical Data management, CRF Designing (Demography, SAE, Physical Examination, Disease specific CRF, etc.), Protocol Designing, GCP, CDISC Standards, 21CFR part 11, MedDRA theoretical Knowledge.
- Clinical Trial Database (Open clinical, Overview of Oracle clinical)
- In Dept knowledge of RAVE database and complete working knowledge (both setup and conduct)
- SAS (Base, STAT, Proc SQL, MACRO, GRAPH).
Computer and software Knowledge
- MS- Word, MS- PowerPoint, MS- Excel
- SAS 9.0, 9.2 and SAS Enterprises guide
- Operating System : Windows 95, 98
- Computer Qualification : C, C++, JAVA, ASP.NET

[Guest]

Dr. AYHAM FAWAZ SHEIKH
ayham29fawaz AT gmail.com

OBJECTIVE
To build career as a clinical research management professional with sincere dedication towards the esteem organization and to help organization to achieve it’s goal with effective decision making and problem solving skill, with other members.
EDUCATIONAL QUALIFICATION
- Post Graduate certificate course in clinical research & clinical data management (CRCDM) Jan 2008 – June 2008
Pune University’s bioinformatics center, GPA : 4.4
Pune, India Grade : B
Relevant Coursework :
Project Management & Principles of Pharmacoeconomics, Pharmacovigilance, Drug Development Process and Pharmacogenomics, Protocol Designing, Good Clinical Practice (ICH-GCP) & Ethics in Clinical Research, Drug Regulatory Affairs, GxP & Quality Auditing Practices, Site Management & Monitoring, Clinical Data Management, Good Quality Control Laboratory Practices, Medical Writing & Documentation
Academic project : -“Study safety and efficacy of drugs in psoriasis”.
- Bachelor of Homoeopathic medicine and surgery (BHMS)

Antarbharti Homoeopathic Medical College, Nagpur Aug1999-May04
Nashik University, India. Class : - I
Relevant Coursework :-
Study of anatomy and physiology, study of biochemistry, pathology, forensic medicine, preventive and social medicine, general surgery, ophthalmology, ENT, Medicine, Homoeopathic medicine, Homoeopathic Pharmacy, Organon of medicine.
Academic project : Study and comparison of homoeopathic medicine i.e. nosodes and sarcodes

PROFESSIONAL QUALIFICATIONS
- worked as Medical Officer in Ruby hall clinic, Pune .
- Currently working as a clinical research study co-ordinator in neurology and doing trials as follows :
participation in clinical trials
Indication of Trial
Clinical Phase of Trial (I-IV)
Role in Trial (e.g., Co-Ordinater)
Year in which trial was conducted
COMPUTER KNOWLEDGE
Familiar with Microsoft office, Internet, Computer Fundamentals, Microsoft Window operating system. Microsoft word.
EXTRACURRICULAR ACTIVITY
SCOUT in scout guide campaign for 3 yrs
Life-member of UDAN Homoeopathic study circle, Amravati.
CAREER INTEREST

Project management team member as a CR executive
Pharmacovigilance
Clinical Research Associates
Clinical Data Management

[Dr Medha Ambekar]

With reference to the link on indiajobtalks I am posting herewith my resume for your kind consideration
RESUME
Dr Medha Mahindra Ambekar
EMAILID :ambekarmedha12 AT gmail.com

REASON FOR APPLYING : Looking for a diversification
ACADEMIC QUALIFICATIONS :
- SSC : 86% aggregate with 147/150 in mathematics (Year of passing 1982)
- HSC : 86% aggregate (Year of passing 1984) with
- 98/100 in Physics
- 97/100 in Chemistry
- 88/100 in Mathematics
- 87/100 in Biology
- MBBS : From Mumbai University (Year of passing-1989)
- Postgraduate Diploma in Marketing Management : From IGNOU
ACADEMIC ACHIEVEMENTS :
- First in Mumbai University in final MBBS (1989 batch)
- First in Surgery
- Excellent grades in PGDMM
EXPERIENCE : Roaring medical practice for the past 19 years
SKILLS : Excellent command over spoken and written English
Ability to go to the depth of a subject
Excellent communication skills