Vacancy in Parexel for the post of Clinical Research Operator

By: Mitul Shah | Views: 3434 | Date: 07-Jul-2010

The COL is responsible for coordinating the functional team members and their activities across all geographies, liaising with project management and the sponsor to ensure that the Global Research Operations

Over the past 27 years, PAREXEL has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 54 countries around the world, and has over 9,500 employees.
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.

Post: Clinical Operations Leader

Job Description:
The COL is responsible for coordinating the functional team members and their activities across all geographies, liaising with project management and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The Lead has overall accountability for the execution of the operational strategy and plan within Global Site Management.
May act as Project Lead for projects involving a small number of services, where no Project Leader is assigned, tasks assigned as the responsibility include all aspects of the COL discipline.

Key Accountabilities
Client Liaison
'Effectively communicate with internal and external customers as well as third party vendors
'Prioritize effectively and respond to urgent requests within team or from sponsor lead

Project Initiation & Planning
'Provide input to project tools, PM project plan, Central File Maintenance Plan
'Provide input to the format and content for sponsor reports.
'Provide input to and oversight of site selection strategy plan.
'Develop site selection, monitoring and data acquisition and cleaning plans for the COL team
'Review and provide input into patient recruitment plan
'Ensure all team members have access to tools and documents
'Establish efficient / effective working relationships with other project leads and coordinators
'Develop all study plans, tools and forms

Project Implementation, Control & Evaluation
'Provide leadership and direction to COL project team members
'Identify, organize and deliver (where appropriate) study specific training in collaboration with PL and PS
'Evaluate and identify resourcing needs and continuously monitor over life cycle of project
'Provide productivity targets to project team member
'Provide performance feedback on team members as appropriate
'Address identified and escalated site issues and drive to closure
'Early recognition of areas of potential problems and provide input to contingency plans
'Monitor study timelines, patient recruitment and data cleaning to ensure successful outcome of the project
'Oversee maintenance and quality check of COL CF
'Maintain and assure quality of work generated
'Implement and instigate process improvements within the project
'Provide input to the Revenue Recognition forecast
'Identify changes in scope and liaise with Project Leader
'May be required to visit site(s) as per client or project demands.
'Participate in client, investigator and team meetings
'Prepare, participate in and follow up on audits / inspections
'Participate in all required Lead trainings

Project Close-out
'Coordinate database lock activities.
'Together with PL oversee all administrative closeout procedures are completed, according to Project Closeout Checklist
'Together with PL ensure project is archived and all documentation returned to the client as specified the by the contract.
'Participate in end of study meeting and give input to lessons learned information

'Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
'Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Candidate Profile:
'Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word
'Strong regulatory knowledge including GCP
'Excellent interpersonal, oral and written communication skills
'Excellent problem solving skills
'Strong negotiation and diplomacy skills
'Ability to lead a 'virtual', global team as required
'Carefully weighs the priority of project tasks and directs team accordingly
'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
'Ability to successfully work in a team environment
'Enlists the support of team members in meetings goals
'Excellent presentation skills
'Good consulting skills
'Strong customer focus, ability to interact professionally within a client organization
'Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
'Ability to take initiative and work independently
'Sense of urgency in completing assigned tasks
'Ability to conduct root cause analysis in business problem solving and process improvement development
'Ability to lead a distributed team ' virtual team management across locations and cultures
'Ability to identify and address issues proactively
'Effective time management in order to meet daily metrics or team objectives
'Shows commitment to and performs consistently high quality work
'Ability to travel as required

Degree in a life science, nursing qualification or relevant experience

Language Skills
'Competent in written and oral English

Minimum Work Experience
'Substantial experience of 5+ yrs in clinical research including relevant experience as a team leader in Clinical or Data Management functions or proven experience in coordinating clinical trials. Individuals should have a strong understanding o cross functional activities related to data processing, cleaning and site management

Note: Candidate with Relevant working Experience of 5+ yrs in Clinical Research and of which at least 2+ years in Leading a Team can directly send their CV to
Additional Information:
Experience: 5+ years
Hyderabad / Secunderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR

send YOUR CV to,
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