Covance

Associate Director, Medical Data Review

Job Location(s) IN-Bangalore
Job Number
2020-50205
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 Covance 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 supervisor
- If acts as line manager, the following responsibilities apply. 
- 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 Covance as a leader in the Field of CM/MDR

Education/Qualifications

Medical Doctor, Para-professionals, M-Pharmacy, Life Science Graduate

Experience

Medical doctors with 7-10 years of experience in medical practice/Medical Data review/equivalent clinical research roles or Para professionals and Life science graduates with 9-11 years of clinical research/equivalent experience

Options

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