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Multiple Vacancies in PAREXEL : Require Clinical Research Associate II, Clinical Data Analyst II, Senior Clinical Data Analyst, Senior Project Quality Lead, Clinical Data Analyst II (Clinical Coder), Quality Specialist

 

Clinical courses

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

POSTS:

Post: Clinical Research Associate II

Description:
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations.


Responsibilities
- Performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required),
Performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Experience:
Skills & Experience
- Minimum 2.5years of On-site Monitoring in Multinational, Multi-centric trials.
- Educated to minimum of Graduation in LifeScience
- Excellent Communication skills


Additional Information:
Location: Mumbai, Gurgaon
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th July, 2012
Job ID:
2624440, 2624456

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Post: Clinical Data Analyst II

Description:
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

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

Experience:
- 2 to 4 yrs of relevant experience in Clinical Data Management would be preferred
- Educated to minimum of Graduation in LifeSciences or equivalent experience

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th July, 2012
Job ID:
2626763

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Post: Senior Clinical Data Analyst

Description:
Key Accountabilities
- Assume the ability to meet the requirements of a CDA I and II with a high degree of proficiency and autonomy
- Act as an independent CDM Coordinator on complex or multiple projects, CMA/CDA Coordinator on smaller projects
- Manage all phases of data management activities from study start up to database close
- Direct team members in daily activities
- Define and monitors metrics and modifies plan accordingly
- Mentor project team members
- If required, facilitate cross functional team meetings both internally and externally
- Actively review and provide feedback on study productivity
- Recognize out of scope activities and communicates to GRO Lead
- Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings / conferences
- Keeps manager(s) informed about work progress and any issues to avoid surprises. Requires minimal supervision by Manager
- Apply knowledge across multiple projects
- Define study specific processes
- Identify inconsistencies and inefficiencies in processes and recommends solutions

Skills
- Excellent interpersonal, verbal and written communication skills
- Excellent computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office products such as Excel, Word.
- Sound awareness of all relevant regulations, including GCP
- Posses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock
- Carefully weighs the priority of project tasks and directs team accordingly
- Understands the strengths and development areas of team members
- Ability to lead a virtual, global team as required
- Gives others appropriate latitude to make decisions
- Looks for win-win solutions to solve problems
- Ability to make appropriate decisions in ambiguous situations
- Ability to solve problems by using a logical, systematic, sequential approach
- Communicate and work effectively with clients
- Enlists the support of team members in meetings goals
- Proposes new approaches, methods or technologies
- Anticipates how others will react to situations
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Plans and delivers verbal and written communications that persuade the intended audience
- Willing and able to travel as required local or international

Experience:
- Previous relevant working experience preferred, or data management, clinical and / or research experience with solid understanding of clinical trials methodology and terminology 4 Yrs. to 7 Yrs of relevant experience

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th July, 2012
Job ID:
2626754

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Post: Senior Project Quality Lead

Description:
Provide quality oversight to project team management throughout the project. Specifically responsible for standard and risk-based quality interventions including: review of key project documentation, consultation, CAPA support, audit and inspection support, and collection and reporting of project quality metrics. Mentor Project Quality Leads I and II, as assigned.

Experience:
6 to 8 years of total experience with at least 4-5 years of relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th July, 2012
Job ID:
2619042

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Post: Clinical Data Analyst II (Clinical Coder)

Description:
Essential Function
To work within the coding group to ensure provision of timely, accurate and consistently coded and reviewed terms for the Data Management teams, and other groups where appropriate, to the highest standards of quality and efficiency representing the best interests of PAREXEL, and the client, at all times.
Identify and apply appropriate codes from specific dictionaries to Case Report Form (CRF) terms that require manual coding (e.g. adverse events, medications/procedures, and medical conditions/history).
- Accurately and consistently apply coding conventions to Case Report Form terms in accordance with all applicable procedures.
- Review all coded terms within the clinical database for accuracy and consistency and appropriately address coding discrepancies or inconsistencies.
- Accurately generate data queries where applicable to resolve coding discrepancies.
- Maintain coding documentation within project files as appropriate.
- Assist with the development, review and update of Data Management Coding Study Specific Procedures when applicable.
- Generate and review status reports and metrics as appropriate.
- Represent Coding group at internal / external meetings as appropriate.
- Effectively mentor less experienced staff. This may include assisting and guiding new personnel during their initial training period.
- Perform other duties reasonably related to the position as directed by manager/designee.

Key Accountabilities
- Management of all auto encoding and manual coding of medical terms and medications as specified by the sponsor. Management of all software and tool that form part of this process,
- Preparation and review various coding reports as required in order to ensure quality, consistency, accuracy and manual review for specialized forms of data cleaning such as Clinical Coding, .
- To Adhere to all SOPs, company and regulatory documents as required by PAREXEL
- To assist Clinical Data Managers with understanding and interpretation of data to be entered onto the database for medical conditions, adverse events, medications, laboratory data, ECG information, X-ray data, and any other data items where knowledge of medical terminology and clinical conditions is required for the accurate and consistent documentation of study findings
- Perform tasks with minimal supervision and take direction from Line manager, Coding managers and Quality managers.
- Performs Clinical Coders function to meet / exceed interval metrics, client satisfaction

Experience:
Skills
- 2 to 5 years relevant Experience
- Excellent verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- Demonstrate a sound awareness of all industry standard coding dictionaries (MedDRA, WHODRUG etc.)
- Ability to search and use the internet to reference medications/treatments where not listed in other sources.
- Demonstrate a sound awareness of all clinical coding tools and systems used within PAREXEL and good awareness of tools / systems used within the industry as a whole
- Shows commitment to project and departmental goals, motivating others to be successful
- Demonstrate a sound awareness of all relevant SOPs, regulations, including GCP
- Ability to solve problems by using a logical, systematic, sequential approach
- Proposes new approaches, methods or technologies to gain efficiencies and exceed customer expectations
- Shares all relevant information with the global coding team and identifies escalations as appropriate

Education
- Bachelor's degree or higher and / or other medical qualification.

Language Skills
- Excellent English written and oral communication skills

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th July, 2012
Job ID:
2616000

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Post: Quality Specialist

Description:
Serve as a quality consultant to designated operational group(s). Activities include: identification of process improvement opportunities, process authoring and review, support for process re-engineering, providing GxP and process expertise to designated operational group(s), support for identification, management and prevention of quality issues, providing audit and inspection support, and assist with the collection and reporting of quality metrics as assigned.

Experience:
3-6 years of total experience with relevant pharmaceutical industry, or CRO experience

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 20th July, 2012
Job ID:
2624354

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Title: Quality Specialist I, Process QM

Description:
Essential Function
- Supports the CAPA Program Management group in the development and implementation of training materials, process documentation and general administration of the CAPA system to improve, evolve and maintain the CAPA Program across PAREXEL worldwide.

Key Accountabilities
- Assist the CPM team in the development and implementation of appropriate training material and process documentation or Job Aids.
- Actively participate in internal CAPA meetings/forums including overall management of meeting schedules, minutes and communication to end users.
- Assist QuIPS development team with general monitoring and support as assigned by team leads.
- Assists with maintenance of CAPA Program page in PAREXEL Connect as necessary.
- Assists with general administration of data contained in the Quality Issue Process System (QuIPS), including basic oversight and support to end users.
- Maintain a thorough understanding of PAREXEL standard operating procedures that are relevant to project(s).
- Remain informed about developments in relevant regulations and guidelines.
- Share information in a timely fashion and in an open, balanced and objective manner.
- Other duties as assigned.

Experience:
Skills
- Ability to learn and understand the business to support development or enhancement of established procedures.
- Excellent interpersonal, verbal and written communication skills.
- Personal qualities that include the ability to gain trust and confidence with a variety of customers within PAREXEL.
- Internal customer focused approach to work.
- Computer literacy, to include MS Windows and Office.
- Positive attitude and ability to adjust to changing priorities, unforeseen events and ambiguity.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Ability to make appropriate decisions in ambiguous situations.
- Culturally aware and ability to think and work globally.
- Ability to work with virtual/global teams and travel as needed

Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th July, 2012
Job ID:
2622888

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