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Oppurtunity for Clinical Data Analyst At PAREXEL
Posted November 21, 2011
· 2 - 4 Years
Organization
PAREXEL International
For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com.
For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com.
Role
Designation Clinical Data Analyst II
Job Description
Clinical Data Analyst II
The role of the Clinical Data Analyst (CDA) is to independently perform all clinical data cleaning activities on assigned
projects, commensurate with experience and/or project role. Key activities include data validation, generation and
integration of queries, coding of clinical data, reconciliation of safety and electronic data
Key Accountabilities
Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
Train team members on selected tasks
Prepare Data Cleaning Specification
Review the Data Validation Specification prepared by the Technical Analyst in GTS
Develop or provide input to project specific guidelines, e.g. SAE handling.
Initiate the running of study specific programs
Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
Conduct in-house data review,
Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
Identify and report protocol violations
Manual and Patient Profile review, issue queries
Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their
action
Track and integrate queries
Perform clinical coding if appropriate to role within the project team
If required liaise with 3rd party vendors to clean electronic data
Ensure all documents coded for submission to central files
Lock site(s) within EDC system - remove user's data modification privileges
Interact with site (via mail) as required
Perform early and final database QC activities
Update all relevant tracking system on an ongoing basis
Inform responsible CDA Coordinator of work status regularly
Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by
Manager or assigned mentor
Desired Profile
Experience:
Minimum Relevant Experience of 2 to 4 years
Skills
Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of
MS-Office products such as Excel, Word
Sound awareness of all relevant regulations, including GCP
Ability to successfully work in a ('virtual') team environment
Client focused approach to work
If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
Effectively applies knowledge to provide advice or solutions based on expertise
Offers support and constructive feedback to project team members
Seeks opportunities to develop experience and knowledge
Ability to organize and plan tasks
Excellent interpersonal, verbal and written communication skills
Must be able to work independently but seek guidance when necessary, escalating issues as required
Sense of urgency in completing assigned tasks
Meticulous attention to detail
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Willing and able to travel as required ' local or international
Education
Bachelor's degree and / or other medical qualification or relevant DM experience
Language Skills
Competent in written and oral English
Minimum Work Experience
Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical
trials methodology and terminology
Education
Bachelors degree and / or other medical qualification or relevant DM experience
Language Skills
Excellent in written and oral English
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Other
Functional Area Other
Education UG - B.Pharma - Pharmacy,B.Sc - Any Specialization, Biology, Microbiology, Nursing, Zoology,B.Tech/B.E. - Any
Specialization, Bio-Chemistry/Bio-Technology, Biomedical,BDS - Dentistry,MBBS - Medicine
PG - Any PG Course - Any Specialization,M.Pharma - Pharmacy,M.Sc - Any Specialization, Biology, Microbiology, Nursing,
Zoology,M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical,M.S/M.D - Any Specialization, Cardiology,
Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Obstretrics,
Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, Urology
Location Hyderabad / Secunderabad
Keywords Clinical Data Management, CDM, Query Management, INFORM, Oracle Clinical, OC, RAVE, Discrepancy Management
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com
Job Description
Clinical Data Analyst II
The role of the Clinical Data Analyst (CDA) is to independently perform all clinical data cleaning activities on assigned
projects, commensurate with experience and/or project role. Key activities include data validation, generation and
integration of queries, coding of clinical data, reconciliation of safety and electronic data
Key Accountabilities
Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
Train team members on selected tasks
Prepare Data Cleaning Specification
Review the Data Validation Specification prepared by the Technical Analyst in GTS
Develop or provide input to project specific guidelines, e.g. SAE handling.
Initiate the running of study specific programs
Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
Conduct in-house data review,
Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
Identify and report protocol violations
Manual and Patient Profile review, issue queries
Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their
action
Track and integrate queries
Perform clinical coding if appropriate to role within the project team
If required liaise with 3rd party vendors to clean electronic data
Ensure all documents coded for submission to central files
Lock site(s) within EDC system - remove user's data modification privileges
Interact with site (via mail) as required
Perform early and final database QC activities
Update all relevant tracking system on an ongoing basis
Inform responsible CDA Coordinator of work status regularly
Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by
Manager or assigned mentor
Desired Profile
Experience:
Minimum Relevant Experience of 2 to 4 years
Skills
Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of
MS-Office products such as Excel, Word
Sound awareness of all relevant regulations, including GCP
Ability to successfully work in a ('virtual') team environment
Client focused approach to work
If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
Effectively applies knowledge to provide advice or solutions based on expertise
Offers support and constructive feedback to project team members
Seeks opportunities to develop experience and knowledge
Ability to organize and plan tasks
Excellent interpersonal, verbal and written communication skills
Must be able to work independently but seek guidance when necessary, escalating issues as required
Sense of urgency in completing assigned tasks
Meticulous attention to detail
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Willing and able to travel as required ' local or international
Education
Bachelor's degree and / or other medical qualification or relevant DM experience
Language Skills
Competent in written and oral English
Minimum Work Experience
Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical
trials methodology and terminology
Education
Bachelors degree and / or other medical qualification or relevant DM experience
Language Skills
Excellent in written and oral English
Experience 2 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Other
Functional Area Other
Education UG - B.Pharma - Pharmacy,B.Sc - Any Specialization, Biology, Microbiology, Nursing, Zoology,B.Tech/B.E. - Any
Specialization, Bio-Chemistry/Bio-Technology, Biomedical,BDS - Dentistry,MBBS - Medicine
PG - Any PG Course - Any Specialization,M.Pharma - Pharmacy,M.Sc - Any Specialization, Biology, Microbiology, Nursing,
Zoology,M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical,M.S/M.D - Any Specialization, Cardiology,
Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Obstretrics,
Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, Urology
Location Hyderabad / Secunderabad
Keywords Clinical Data Management, CDM, Query Management, INFORM, Oracle Clinical, OC, RAVE, Discrepancy Management
Contact PAREXEL International (India) Pvt Ltd
Website http://www.parexel.com