Clinical Data Management : Resume CV

[PinakiKK]

KARMOKER Pinaki
Email : pinaki.meetme007 AT gmail.com

Summary :
- A professional in the filed of clinical data management with an exp. of 4 and half years.
- Performance of Lead activities in multiple phase III, IV & II projects.
- Attended face to face over-seas customer meeting in terms of presenting the study specific data management plan documents and obtaining customer agreement and approval.
- Current job role includes relationship build up with customer, global study Project Manager and project counter part along with mentoring study team members on day to day project operations and leading study team.
- Played the role of QC coordinator in several Phase IV and III studies. (To mention, for a Phase IV study, played the QC coordinator role of 22000+ patients successfully and acknowledged by customer).
- Experienced in vendor and contract set up, monitoring and executing project requests within the assigned scope of work. (CRF printing and distribution activity)
- Knowledge of protocol review.
- Thorough knowledge of edit check writing and designing CRF for phase III, II and IV studies.
- Knowledge of bio equivalent studies, ICH-GCP and data management operating procedures. Brief knowledge on project finance, project utilization and project realization.
- Thorough knowledge of data validation processes (like Discrepancy review, DCF life cycle etc.) including Quality control and Serious adverse event reconciliation process.
- Leading a team of special projects responsible for productivity metrics publication on a monthly basis at project level. Also, contributing in the process improvement project for productivity.

Education / Qualifications :
Date Place of Education Qualifications :
2005 Bangalore University, (Bangalore), India Msc.Biotechnology
2003 Bangalore University, (Bangalore), India Bsc.Biotechnology

Employment History :
Employer/From – To Roles & Responsibilities
Quintiles Technologies (INDIA) Pvt Ltd.

Current : Asst. Clinical Data Manager
- Serve as a Data Team Lead (Project lead) for one protocol with more than 5 operations staff (excludes Data Entry) or a leadership role in a specific area or process on a large study with guidance.
- Manage delivery of projects through full data management study life-cycle (with minimal guidance).
- Handling Functional team
- Resource development plans
- Budget allocation review and revenue recognition
- Manage project timelines and quality; determine resource needs; identify out-of-scope work.
- Perform comprehensive quality control procedures.
- Perform CRF designing
- Develop Data Management Plan documents
- Conduct data review.
- Write and resolve data clarifications.
- Lead database audit team
- Develop and test databases and edit specifications
- Understands and comply with core operating
- Develop and maintain good communications and working relationships with CDM team.

Project Experience and Therapeutics Areas overview :
Phase
Indication
Number of Countries Number of Sites & Patients Description of Responsibilities and Tasks
Phase IV
Viral infection-influenza
World wide 120 & 8000 Data Coordinator
Phase III HIV-Lipodystrophy syndrome World wide 62 & 1500 Data Coordinator
Phase II Hepatitis cancer

World wide 24 & 300 Data Coordinator :
Phase II Lung Cancer World wide 24 & 300 Data Coordinator
Phase III Intra Cerebral Haemorrhage World wide 55 & 750 Data Coordinator and process lead
Phase IV Diabetes Mellitus –Type II World wide 2400 & 52000 Data Team Lead
Phase IV Anemia World wide 77 & 930 Data Operation Coordinator, team lead
Phase II Rheumatoid arthritis World wide 52 & 300 Data Operation Coordinator, team lead
Phase II Rheumatoid arthritis World wide 44 & 290 Data Operation Coordinator, team lead
II Paediatric dystrophy World wide Multicenter and 1000 Lead activities

In depth knowledge :
Microsoft Word (2003 & 2007), Microsoft Excel (2003 & 2007), Microsoft PowerPoint (2003 & 2007), Microsoft Office Outlook (2003), Lotus Notes and Microsoft Office Communicator (2005). Microsoft Projector 2003,
CDMS Platforms
Oracle Clinical 4.0.3 and 4.5.1
Fortis 2.2
Medidata rave
Inform 4.6
Standard Reports :
Tracking CRF-DCF Reports
TOAD
Crystal Report
SAS V9 report
- Brief overview of programming knowledge
- Mapping of shared net work drive
- Overview of people soft and ceredian time coding tools
Other Relevant Details

Systems Experience/IT Skills :
Professional Honours and Awards :
- Awarded- 'Instant Award' for distinguished and remarkable performance in QC Coordinating for a phase III study.
- Awarded- 'Instant Award' for consistent performance with a productivity of 120% and 100% quality in the validation process.
- Nominated and awarded - 'Team of the Year Award' due to tremendous and extraordinary performance to get the project locked successfully which also delighted the Customer and helped in achieving repeat businesses.
- Nominated and awarded twice- 'Data Validator of the Month' for consistent and sincere performance without missing a single day TAT and with 100% quality to drive the critical DV process handling.
- Achieved customer Loyalty Award as a member of a project team which resulted in customer delightment and appreciation which enabled to pursue repeat business.
- Awarded an applause award for outstanding conributiuon in Six Sigma projects in terms of productivity metrics repor publication.

PERSONAL PROFILE :
DOB : 1st March 1982
Marital Status : Married
Nationality : Indian
Languages Known : English, Hindi, and Bengali

Personal Achievements :
- Secured First Prize in painting from the Dist. Howrah, West Bengal, India, for the graduation course conducted by Rabindra Bharti.
- Played club level Cricket under C.A.B (Cricket Association of Bengal).
- Certified as graduate in playing Tabla from Rabindra Bharti.

Thank you

[Guest]

MAHADEVAMMA L
E-mail : savipharma AT gmail.com

OBJECTIVES :
Seeking a position of responsibility where my professional educational experience would be utilized to shape up a career in a reputed company to which all my efforts are dedicated upon. I would like to provide my skills at the disposal of an Organization that recognizes my potential and offers me a challenging, stimulating and learning environment to work in that are beneficial to both Organization and myself.

EDUCATION :
Exam Passed Discipline Institute Year of Passing Class Obtained % Obtained :
M.Pharmacy Pharmacy Practice Sri Adichunchanagiri College of Pharmacy B.G.Nagar 2011 First 74.57 %
B.Pharmacy Pharmacy Sarada Vilas College of Pharmacy, Mysore 2009
First 64.59 %
D-Pharmacy Pharmacy Bharathi College of Pharmacy, Mandya 2005
First 64.32 %

CLINICAL PHARMACY ACTIVITIES DURING M.PHARMACY :
- Active participation in the following activities of Clinical Pharmacy at Adichunchanagiri Hospital and Research Center B.G.Nagara in various departments like General Medicine, Paediatrics and surgery from June 2009 to December 2010.
- Ward Round Participation and Medication Chart Review
- Provision of Drug and Poison Information
Expertise in Bio-medical literature search by using different databases such as Micromedex, and IDIS for the provision of poison and drug information to the healthcare professionals.
- Detection and Identification of Adverse Drug Reaction,Reporting, Monitoring, and documentation.
Assessing suspected ADRs by using different causality assessment scales
- Efficient in “Patient Counselling” and “Designing Patient Information Leaflets (PILS)”
M.PHARM DISSERTATION
“PROSPECTIVE STUDY ON THE INCIDENCE AND PATTERN OF POTENTIAL DRUG INTERACTIONS OF ANTIMICROBIAL AGENTS IN THE DEPARTMENT OF MEDICINE IN A TERTIARY CARE TEACHING HOSPITAL”
PREVIOUS GUIDE : Dr.Jimmy Jose, H.O.D, Dept of Pharmacy Practice, S.A.C. College of Pharmacy, B.G.Nagara
PRESENT GUIDE & H.O.D : Dr. BJ Mahendrakumar. Professor, Dept of Pharmacy Practice, S.A.C. College of Pharmacy, B.G.Nagara

E X P E R I E N C E :
- ATTAINED TRAINING AT MANDYA DISTRICT HOSPITAL AS A PHARMACIST FOR THREE MONTHS AS A PART OF ACADEMICS.
- UNDERGONE TRAINING AT AYUR DRUGS AND PHARMACEUTICALS IN MANUFACTURING OF LIQUIDS, ORALS, TABLET, OINTMENT PREPARATIONS AND CAPSULE FORMULATIONS FOR A DURATION OF ONE MONTH AS A PART OF ACADEMICS.S
- WORKED AS A PHARMACIST IN VIKRAM HOSPITAL FOR A PERIOD OF SEVEN MONTHS, MYSORE.

WORKSHOP/CONFERENCES ATTENDED :
1) “PHARMACOVIGILENCE” ON 12/08/2010 AT K.L.E COLLEGE OF PHARMACY, BELGAUM
2) A NATIONAL SEMINAR ON “RECENT TRENDS IN PHARMACEUTICAL CHEMISTRY AND INTERPRETATION TECHNIQUES” DATED 19th and 20th of MARCH 2010 AT S.A.C COLLEGE OF PHARMACY, B.G.NAGARA
3) A NATIONAL SEMINAR ON “RESEARCH IMPLICATION AND SKILL DEVELOPMENT TECHNIQUES IN PHARMACEUTICAL SCIENCES” DATED 27th and 28th of OCTOBER 2010 AT S.A.C COLLEGE OF PHARMACY, B.G.NAGARA
4) “WORKSHOP ON PRINCIPLES OF CLINICAL RESEARCH” DATED 27th and 28th OF NOVEMBER AT J.S.S COLLEGE OF PHARMACY, OOTY
A C C E P T E D O R A L I N T E R A N A T I O N A L C O F E R E N C E I N A S I A N
- Assessment of incidence and pattern of potential drug interactions of antimicrobial agents in tertiary care teaching hospital of South India
- Assessing the Knowledge, Attitude and Medication Adherence among Asthma patients in a rural population
ACCEPTED IN ASIAN JOURNAL OF CLINICAL RESEARCH AND PHARMACEUTICAL
Pattern of potential drug interactions of antimicrobial agents in the department of medicine in a tertiary care teaching hospital : a prospective study

SKILLS :
Personal skills :
- Good communication skills
- Time management
- Working efficiency in a team

Computer skills :
Well versed with Microsoft windows XP, MS OFFICE, (2000, 2003 and 2007 versions) and Internet applications.

AREAS OF INTEREST :
- Clinical Research
- Drug safety Monitoring
- Pharmacovigilance
- Hospital and Clinical pharmacy services

[Guest]

Hi all,
we have some openings for clinical data analyst(2+) positions in Hyderabad. please send your updated resumes to thanuja.qa AT gmail.com
Thanks
Thanuja

[Unregistered]

I have completed my bsc(micro) and pg dmlt, but i m interested in clinical data management and m luking 4 good resume, I am having educational gap between my bsc and Post graduation, kindly help me with good resume sample.

If reader has solution, kindly reply on email id mirchandanijaya08 AT gmail.com.

Thanks for reading and forwarding.