Director Clinical Monitoring @ inVentive Health Care B12

JOB DESCRIPTION:
The position provides leadership to and is accountable for the Risk Based Monitoring (RBM) Operations in India

MAJOR RESPONSIBILITIES:

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.

EDUCATION REQUIRED:

Bachelors degree in a related field or equivalent combination of education, training and experience

MINIMUM TRAINING & EXPERIENCE REQUIRED:

A minimum of nine years of experience in clinical research and preferably across more than one functional department
A minimum of six years experience in the management of clinical monitoring and/or project management staff
Experience working across geographies and across functional departments
Demonstrates strong leadership and line management skills
Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
Excellent written and oral communication skills (including English)
Strong communication, interpersonal, time management and organizational skills
Ability to operate and use various systems and databases (CTMS, dashboard analystics) to analyze trial data and identify trends/outliers

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