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Post: Director Clinical Monitoring
Job Description
General Management Responsibilities
- Provide direction, coaching and career development guidance to direct reports
- Coordinate and conduct new employee orientation and training
- Identify and address performance and quality issues and training needs
- Assess, track and manage direct reports’ activities to ensure compliance to policies, SOPs , federal and local guidelines and GCPs, as well as departmental metrics
- Assess workload of direct reports and participate in staffing and resource allocation process
- Support administrative tasks including staff recruitment and interviewing, review of expense reports, timesheet review and any other applicable activities
- Participate in applicable internal or external meetings, such as client meetings, audits and inspections
- Provide business development support as requested
- Participate in committees/work groups to support the implementation and development of new processes and initiatives to improve department operations
- Any other activities as required to achieve business needs
Specific RBM Responsibilities
- Provide strategic leadership and direction to the RBM team in India and if required on a global basis.
- Plan and develop overall strategies for the future of the RBM including needs for systems and resource
- Interface with IT to ensure proper development and maintenance of RBM Systems
- Interact directly with sponsors on a regular basis, particularly when RBM issues arise
- Assume overall responsibility for the efficiency of the RBM, utilizing metrics on quality and efficiency and feedback from external and internal customers
- Assume overall responsibility for RBM in full service and stand-alone projects
- Coordinate the validation of a RBM related supporting software
- Interact with other departments to ensure timely delivery of high quality project deliverables
- Guide CRM to develop process for implementation of Risk Management program within the project team, including study level and site level risks
- Define data review process and thresholds
- Support development of reporting and data display tools
- Ensure adequate deployment of risk assessment and mitigation strategies within and across functions (including but not limited to DM, clinical monitoring, project management, medical, regulatory)
- Leadership in coordinating with global functional leads to ensure effective communication and worldwide implementation
- Monitor effectiveness and identify gaps in the use of the following: Risk assessment tool (including escalation and documentation), Quality Risk Management plan, Functional plans, Centralised monitoring plan, Corrective and Preventative action plan
- Identify appropriate stakeholders and outline review, escalation and communication pathways
- Lead the development of RBM policies, operating guides and lessons learned
- Review and approve training plans for the department and ensure implementation
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.
Will provide line management for people to deliver specific projects / tasks / objectives
Accountable for ensuring that direct reports provide quality deliverables within GCP/ICH guidelines and applicable SOPs and policies.
Accountable for ensuring that assigned risk based monitoring team achieves defined corporate metrics goals.
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Candidate Profile
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A minimum of nine years of experience in clinical research and preferably across more than one functional department
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A minimum of six years experience in the management of clinical monitoring and/or project management staff
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Experience working across geographies and across functional departments
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Demonstrates strong leadership and line management skills
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Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
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Excellent written and oral communication skills (including English)
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Strong communication, interpersonal, time management and organizational skills
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Ability to operate and use various systems and databases (CTMS, dashboard analystics) to analyze trial data and identify trends/outliers
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Bachelor’s degree in a related field or equivalent combination of education, training and experience
Additional Information:
Experience: Min. 9 Years
Job ID: 7050
Location: India
Industry Type: Clinical Research
Functional Area: CR
Last Date: 31st May, 2014
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