Covance

Associate Director (Centralized Monitoring)

Job Location(s) IN-Bangalore
Job Number
2021-64074
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

Job Overview

- Plans, prepares and reviews sponsor presentations/bid defense support.
- Oversees proposal and costing outputs to ensure consistency with overall proposal strategy and development
- Oversees at a strategic level the appropriate tracking, interpretation and application of data to proactively manage risk
- May act as subject matter expert based on education qualification/experience.
- Ensures quality and relevance of Medical data review and appropriate review levels, aligned with central monitoring strategy
- Ensures medical data review requirements and strategies align with client expectation and Labcorp Drug Development standards.
- Oversees the completion of the central monitoring / Medical Data review toolkit build
- Ensures quality and relevance of Medical Data Review Plans.
- Ensures the value add of the Medical Data Review Dashboard in support of current and ongoing studies, report progress, quality and ensures compliance to RBM plan.
- Oversees at a strategic level Medical Data Review activities to ensure continuous improvement and compliance.
- Oversees Project Quality to ensure client portfolio satisfaction and compliance.
- Promotes XMR to project teams, internally and externally.
- Leads the development and maintenance of CMR processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
- Approves and oversees the implementation of improvements to XMR and Medical Data review processes.
- Promotes continuous improvement and oversees implementation of improvements to the Medical Data Review systems and tools.  
- Identifies and presents global strategic options and study challenges/opportunities with the client during proposal, bid defense and study implementation.
- Demonstrates visible leadership to clients through effective risk management and generation of customer solutions.
- Line management
- Any other duties assigned by supervisorIf acts as line manager, the following responsibilities apply.
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- Recruit, retain, motivate and "energize" well qualifies CM/MDR. Establish Goals, supervise, mentor, evaluate and motivate strong performance in CM/MDR and serve as a strong member of the local/regional leadership team.
- Promote Staff development career and succession planning, improvement in interpersonal and leadership skills and achievement of Competency standards.
- Lead/Support the implementation of short-term and long term strategies to improve CM/MDR efficiencies (Locally and/or regionally) through collaboration with senior management and peers from other sites.
- Prevent and/or deal decisively and effectively with the obstacles that put achievement of the goal at risk, including poor performance, attrition, peak/valleys of work volume, project scope changes and the myriad of issues that are common to clinical trials (Delays, system glitches, errors, audits, shifting deadlines, misaligned expectations, etc.,)
- Support business development and marketing activities at client presentation and professional seminars and coach junior staff to develop the skills to do likewise.
- Demonstrates visible leadership to clients through effective risk management and generation of customer solutions.
Network with Peers, participate in professional meetings, review literature and research process, standards, technologies for improving practices and efficiencies while representing Labcorp Drug Development as a leader in the Field of CM/MDR

Education/Qualifications

Medical Doctor, M-Pharmacy, Life Science Graduate

Experience

We are seeking candidates with 15+ years of experience in Clinical/Centralized Monitoring or Risk Based Monitoring experience

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