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, they 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. They 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.
POSTS:
- Clinical Data Analyst II (Below)
Post: Clinical Data Analyst II
Job Description:
• 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
Candidate Profile
• Bachelor’s degree and / or other medical qualification or relevant 3-6 years of DM experience
• Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical trials methodology and terminology
Additional Information:
Location: Hyderabad, Andhra Pradesh
Experience: 3-6 yrs
Functional Area: CR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th March, 2014
Req Number: pare-10031194
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Post: Drug Safety Associate
Job Description:
Essential Function
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Relationships
Reports To Regional Head of PV Operations/ Associate Team Manager PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety Assistants
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives
Key Accountabilities
• Triage of incoming reports for completeness, legibility and validity
• Initial data entry of case reports into safety database / tracking system
• Assessment of case reports for seriousness, causality and expectedness
• Requesting follow-up i.e. written, telephone
• Adverse event (AE) and drug coding
• Writing case narratives
• Create and maintain project specific working files, case report files and project central files
• Assist with additional Drug Safety Specialist activities as required
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
- collection and review of endpoint packages
- review and follow-up laboratory alerts
- review and follow-up patient eligibility for inclusion / exclusion in clinical trials
- review and follow-up protocol violations
- review study specific Model ICFs according ICH/GCP criteria
• Participate in client meetings / investigator meetings / project specific training sessions
• Delegate work as appropriate to Drug Safety Assistants
Skills
• Understanding of drug safety and the drug development process
• Analytical and problem solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Time management skills
• Team player
• Client focused approach to work
• Experience with basic computer applications
Education (one of:)
• Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
• Associates/diploma degree in any of the above with appropriate work experience
Language Skills
• Fluent English
Qualifications: Related experience gained in Pharmacovigilance or a healthcare environment
Additional Information:
Location: Hyderabad, Andhra Pradesh
Functional Area: DRA
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th March, 2014
Req Number: pare-10031718
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Post: Associate Medical Writer
Job Description:
Job Summary: As an Associate Medical Writer you would work on Clinical Study Documents, mainly Narrative Writing.
Key responsibilities:
Under divisional supervision as needed, the Associate Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with regulatory submissions. The Associate Medical Writer will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Associate Medical Writer may serve as primary technical contact with the client under appropriate divisional supervision.
The position is focused but may not be limited to the handling of documents and communication associated with the submission to Independent Ethic Committee(s) and the local Regulatory Authorities in India or other global regulatory bodies.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Write clinical documents associated with submissions to regulatory authorities including but not limited to Study protocols, Informed consent documents, Clinical study reports, Submission forms for regulatory bodies.
• Prepare clinical study reports to regulatory standard for e-submission.
• Assist with preparation and compilation of appendices to clinical study reports.
• Translate documents to German, as required.
• May supervise collection of materials by Medical Writing Assistant for assembly of client deliverables and for filing appropriately in Central Files, project files and Medical Writing archives.
• Ensure document content and style adheres to appropriate regulatory guidelines, and complies with company or client SOPs and style guidelines, Teamwork within Medical Writing and the Unit
• Attend internal technical team meetings
• May participate in divisional or interdivisional process improvement and training initiatives
• Serve as the Medical Writing representative on assigned project teams.
Candiate Profile
The ideal candidate for this role would be a PhD, MBBS (or equivalent Indian Medicine degree), BDS/MDS, MSc with excellent English Language/Communication skills (the latter is mandatory). Experience in corporate regulatory medical writing is not mandatory however, experience in any type of writing (literature, own research, magazine or newspaper writing) would be an advantage.
Additional Information:
Location: Bangalore, Karnataka
Functional Area: Medial Writing
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th March, 2014
Req Number: pare-10026849
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Post: Senior Associate - Regulatory Affairs
Job Description:
The position will be responsible for all activities required to produce and/or prepare all types of submissions. This includes:
• Document collection/inventory
• Scanning
• PDF conversion
• Bookmarking
• Hypertext linking
• Quality checking
• Clinical data preparation
• eCTD compilation
• Submission validation
In addition, the prospect will possess mastery in the following areas
• MS office tools
• Adobe Acrobat
• Internal/external publishing tools
• Regulatory knowledge
• ICH, US, EU, Japan, HC and ROW
• eCTD/CTD specification
• Public speaking
Additional Information:
Location: Bangalore, Karnataka
Experience: 3-5 yrs
Functional Area: Other
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th March, 2014
Req Number: pare-10031818
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