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Career opportunity in PAREXEL International | Multiple vacancies as Clinical Data Analyst II, Sr Clinical Trial Specialist, Sr Clinical Data Analyst

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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:

  • Clinical Data Analyst II {below}

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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

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Candidate Profile:
- 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 & Qualification
- 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:
Experience: 2-4 Years
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: data management
End Date: 28th may, 2012
ID:
2617219

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Post: Senior Clinical Trial Specialist

Job Description:
- Assume the ability to meet the requirements of a CTS I and II with a high degree of proficiency and autonomy
- Act as an independent Coordinator on projects at a country level
- Proactively assist SSU Key Contact in keeping requirement knowledge databases up to date for e.g. regulatory requirements, contracts, or investigators
- Contribute to the development and implementation of SSU related processes and tools.
- Identify and address possible areas for training accordingly
- Contribute to the development of SSU related training materials and provide training as required
- Mentor and train less experienced staff as appropriate
- Perform quality checks on SSU deliverables performed by more junior staff
- Initiate escalation of significant quality events as required
- As team coordinator define key study start-up deliverables as well as frequency and content of study tracking updates together with PL/COL/SSU Leader
- Support team members with the identification and communication of priorities
- Assist with resourcing of team members, as assigned
- Collect, track and report SSU metrics, as assigned
- Be involved in study-specific process optimization and training material development
- Oversee other clinical study start up activities as required to ensure that the deliverables are met
- Action site selection strategy
- Refine project-specific site selection strategy at a country level
- Identify new potential Investigators and enter/update clean information into the tracking systems
- Ensure feasibility, review and approval of site identification list coming from FCI
- Conduct country specific feasibilities and/or site pre-qualification and/or remote qualification visits and/or site selection activities (except for on-site qualification visits, which will be done by CRAs)
- Create country specific / site specific (if necessary) Informed Consent Form (ICF)
- Review and approve country specific ICFs (if necessary)
- Prepare and negotiate clinical site agreement at a site level
- Customize SRP Guidelines
- Compile regulatory documents in collaborations with the CRA
- On a regular basis conduct outbound and receive inbound calls to:
- Review recruitment plan
- address/resolve issues pending from qualification visit
- address protocol questions
- check on site staff assignment
- request outstanding documents
- Follow-up on appropriate site related questions
- Review and approve SRP
- Immediately update tracking system once regulatory documents are approved
- Adapt drug label for country requirements in cooperation with Regulatory and the Logistics Team (if applicable)
- Organize translations per country/regulatory/client requirements
- Submit safety updates to IRB/IEC (if applicable)
- Prepare and submit MOH/RA documentation and follow-up until final approval received(Initial submission/Amendments), where applicable in fulfilling responsibilities of regulatory services
- Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC)personnel as required
- 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

Candidate Profile:
- Excellent interpersonal, verbal and written communication skills
- Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
- Strong regulatory knowledge including GCP and local laws
- Sound oral and written communication skills
- Sound problem solving skills
- Ability to successfully work in a team environment
- Strong negotiation, diplomacy and team leadership skills
- Ability to lead a ('virtual'), global team as required
- Ability to take initiative, work independently and delegate
- Client focused approach to work with the ability to interact professionally within a client organization
- Ability to prioritize multiple tasks and achieve project timelines
- Carefully weighs the priority of project tasks and directs team accordingly
- Understands the strengths and development areas of team members
- Gives others appropriate latitude to make decisions
- Looks for win-win solutions to solve problems
- Ability to make appropriate decisions in ambiguous situations
- Enlists the support of team members in meetings goals
- Sense of urgency in completing assigned tasks
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel)

Experience:
- 5+years of SSU or CRA experience.
- Educated to minimum of Graduation in LifeSciences or equivalent

Additional Information:
Experience: 5+ Years
Location: Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 28th may, 2012
ID:
2616215

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Post: Senior Clinical Data Analyst

Job Description:
- 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

Candidate Profile:
- 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 & Qualification
- Previous relevant working experience of 4 to 7 years in Clinical data management with solid understanding of clinical trials methodology and terminology would be preferred
- Educated to minimum of Graduation in Lifesciences or equivalent experience

Additional Information:
Experience: 4-7 Years
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: data management
End Date: 28th may, 2012
ID:
2617221

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