Archive for November 30th, 2006

Director –Clinical Data Management, 10 to 15 years of experience, Hyderabad

Posted on November 30, 2006. Filed under: Director, Hyderabad |

My Client,PAREXEL, is one of the largest pharmaceutical services companies in the world, delivers a full range of services and solutions through their 36 offices worldwide.My client is actively on look out for a senior person(director level) who has a rich experience in Clinical Data Management to head their CDM operations in India.
Only those persons with a min of 10-15 years in biotech industry and very specifically in Clinical Data Management may apply for this position. The person must be heading a large CDM division or must be a director of CDM in his current role.

Target Industry: Bio-Pharma
Job Title
Director –Clinical Data Management

Data Management Operations

Service Unit
Clinical Research Service

Hyderabad, India

Essential Function
The Director, Data Management Operations’ essential function is to manage their Regional DM Operations to ensure that PAREXEL delivers quality data management service and projects to clients and achieves agreed upon revenue margins.  Provide overall direction in the areas of proposal development/management, pricing, project management, personnel management and training and participate in client meetings and presentations. Assumes leadership and P&L responsibilities as part of overseeing operations.

Reports To
VP, Head of WW Data Management and Biostatistics and Programming
Directly Supervises
Associate Directors, Group Managers, (Senior) Managers, (Senior) Administration Assistants

Provides Work Direction to
All Regional Data Management Staff
Works Closely with

Functional Directors and Managers, Business Operations, Account Management, Financial Analysts, Clinical, Biostatistics and Programming, Project Management, Project Team Members, Quality Management Group, IS, Technical Operations Group and Human Resources

External Relationships
Sponsor counterparts and functional management, third party vendors, auditors and regulators

Key Accountabilities
* Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
* Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
* Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales
* Promote and support the implementation of the DM vision and strategy, including defining goals and objectives for the region, in line with the strategy
* Ensure resources are managed across the Region, including recruitment, training development, motivation and retention issues
* Provide accurate forecasting figures for the annual budget and manage P&L throughout the year to ensure that the budgetary goals are met or exceeded.  Review productivity and utilization of the group
* Oversee the coordination of data management operations and project deliverables, ensuring productivity and quality are in line with overall functional expectations
* Ensure compliance with relevant regulations, Swoop’s and operating guidelines
* Lead and support the continuous improvement and implementation of processes and technologies within DM
* Contribute to project bids as required, including participation in client presentations as needed. Provide ongoing marketing support to client relations group
* Interface with new and existing sponsors as necessary to build relationships and support Project Management.

* Proven achievement in leading, managing and motivating teams
* Excellent interpersonal, 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 knowledge of all relevant systems and regulations, including GCP
* Demonstrate a sound knowledge of internal CBOPs, CPs, Corporate Quality Manual, WSOPs and Operational Guidelines
* Ability to negotiate with respect and influence to achieve results
* Strategic thinking
* Excellent problem solving, risk assessment and decision making skills
* Willing and able to travel as required – local or international.

* Bachelor’s degree or higher.

Languag e Skills
* Excellent English written and oral communication skills.

Minimum Work Experience ( 10 – 15 Yrs )
* Very strong   work experience in clinical research and clinical data management.

Anil Shrivastava
Outsourcing | Employee Research | Software
# 603, 6th Floor, Aditya Trade Centre,
Ameerpet, Hyderabad – 500038.

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Posted on November 30, 2006. Filed under: Freshers |


BE/ME in Mechanical / Automobile/Computer Science/Electrical & Electronics with a minumum of 70% aggregate from a reputed institution. (2006/2007 Batch)

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