www.kendle.com India : Clinical Data Manager

[mskavi]

Kendle India : Clinical Data Manager

Website:www.kendle.com

Keywords: Clinical Data Manager

Designation: Clinical Data Manager
Experience: 4 - 7 Years
Location: India
Compensation:
These are permanent, full time opportunities and are offered with a competitive salary and comprehensive benefits package.
Education:
UG - B.Sc - Any Specialization
PG - Any PG Course - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 05 Feb

Job Description:
This is a newly created position based in our brand new offices in India, Ahmedabad. Clinical Data Managers within Kendle function as Project Leaders within the Biometrics department and are responsible for managing timelines/deliverables, budgets and a project team. This role requires a candidate who has already managed the clinical data management process, preferably from study start up to database lock, written Data Management Plans (DMPs) and preferably worked on global studies. As a sponsor liason this role requires excellent customer service, indepth ICH/GCP knowledge and communication skills. In return Kendle offers you a clear and exciting career path within the Biometrics team and an opportunity to further develop your project management skills at a global level.

•Manages the CDM budget for assigned projects (full-service). May be responsible for managing Biometrics budget for Biometrics stand-alone projects •Identifies CDM activities outside the scope of contracted work, prepares cost analysis documentation and follows scope issues through to resolution Operations: •Directs the activities of CDM team members to complete project deliverables on schedule and according to quality standards, requirements and project budget from study start-up through archival •Develops and modifies CDM Documents (Data Management Plan, Data Validation Plan) including data cleaning guidelines, conventions, data workflow and other processes which will be followed to meet sponsor contracted deliverables •Coordinates CRF design in accordance with the protocol and established standards if applicable. •Approves the building, testing and validation of the clinical database •Supports the preparation of fee estimates for project proposals, CIS, and contract modifications •Participates at bid defense meetings and sponsor presentations •Provides or arranges for project specific training for CDM team members •Monitors quality of work performed by CDM project team; coaches staff where necessary •Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training •Contributes to performance reviews of project team members

Desired Candidate Profile:
We are keen to review applications from candidates who match the following profile: A Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline. A minimum of 4 years or equivalent experience in clinical data management and 1 year or equivalent experience working in a project management role. Candidate/incumbent should be familiar with using a PC in the Windows environment. Knowledge of CDM database management systems is desirable. Knowledge of regulatory guidelines related to CDM activities is considered important. Working knowledge of English is essential.

Company Profile:
Kendle

Address: Not Mentioned

Email Address: global.recruitment@kendle.com

Telephone: +440-1276-481294

Reference ID:
KIND5787

Keywords: Clinical Data Manager

[cspk229]

Hi,

Please regard this as an application for the position in Clinical Data Management.
I am a Certified Clinical Data Manager[CCDM] from the Society of Clinical Data Management, Possess excellent analytical, inter-personal and organizational skills with proven abilities in project management, process enhancement and training & development.

The enclosed resume provides more details on the above, as well as on other experience, skills, and abilities that I possess.

I would welcome an opportunity to discuss about the position. You can contact me at 9886652604, if you have any further questions, I'd be more than willing to come in and discuss them with you.

Thanks for your time and consideration.

Regards,
Prasanna Kumar
Ph:9886652604

[Guest]

I have send my resume to you.. please use it for further process..

Brijesh Gupta
+91-9548151060

[Guest]

i woulld like join the kendle cro at gandhinagar ...relpy me as vacancy is there...jignesh mistry

[Guest]

D.SESHADRI
E-MAIL ID :
Seshubph AT gmail.com
IT SKILLS :
OS -- WIN XP, 2000
TECHNICAL SKILLS :
SAS Tools : SAS 9.2 SAS/BASE,
SAS/ODS,SAS/GRAPH,
SAS/ADVANCED,
SAS/MACROS, SAS/SQL
CDM : Oracle Clinica
Applications : MS [Word, Excel,
PowerPoint]

AREAS OF INTEREST :

- SAS
- Clinical Data Management
- Clinical Research Coordinator/Associate

CAREER OBJECTIVE :

I am looking for a position that will enhance my skills, providing me ample scope for growth and yet contribute to the organization’s goal by effectively using the conceptual skills and knowledge gained through my education.
EDUCATIONAL QUALIFICATION :
Graduation :
B. Pharmacy : Dr.M.G.R.Medical University
Institute : Pallvan Pharmacy College
Percentage : 63. %
Year of passing : 2011
Intermediate :
Institute : VIKAS JUNIOR COLLEGE, TIRUPATI
Aggregate : 76.3%
Year of Passing : 2006
S.S.C :
Institute : Rayalasemma public School irupathi
Aggregate : 64.%
Year of Passing : 2004

Internship Program
Doing internship in SAS project for 6 months from Moksha Biosciences.
Phase : I
Objective : To determine ADME properties
and Dose range
Therapeutic area : Anti-Diabetic
Tables created : Demography, Concomitant
Medication, Adverse Events
Listings created : Demography, Adverse Events
Graphs created : Bar charts and pie charts
SAS version : 9.1.3
LANGUAGES KNOWN :
English
Telugu
Tamil

Tasks Done:
1) Converted coded to decoded data by using Proc Format
2) Creation of Analytical datasets
3) Validation of Analytical datasets
4) Did statistical analysis by using Proc Freq and Proc Means
procedures
5) Then performed tasks such as transpose. Concatenation and
subsetting of datasets to table layout
6) Created graphs by using Proc Gchart and Proc Gplot
7) Finally created TLG using Proc Report
8) Validation of TLG
COMPETENCIES:
- Fast Learner.

- Willngness to learn. Team facilitator and Hardworker.
- Work effectively with teams.

TRAININGS ATTENDED:
- SAS and CDM (Oracle Clinica) from Moksha Bio Science, HYD.