1+ months

Senior Manager, Centralized / Risk Based Monitoring

West Chester, PA 19380
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

The Senior Manager, Centralized Monitoring is responsible for leading the implementation and conduct of a cross-functional risk based monitoring (RBM) strategy on assigned studies as part of the Data Sciences organization within Global Biometrics.  The position is also responsible for developing the tools necessary to conduct both aggregate level and real-time reviews (i.e. Medidata CSA and Spotfire) according to the Central Monitoring Plan.  Additionally, the Senior Manager, Centralized Monitoring works closely with other groups to gather requirements and develop functional oversight dashboards and visualizations.  This is an office based position in West Chester PA, but relocation assistance is being offered. 

 Major duties and responsibilities:


Lead and implement the risk assessment process on assigned studies and facilitate cross functional stakeholder input.  Senior Managers may be responsible for program level and/or therapeutic area level oversight.
Map study risks to critical data and procedures in order to define the cross functional data oversight responsibilities ensure data consistency and alignment to the defined risks.
Author and maintain the study specific Central Monitoring Plan (CMP) describing both aggregate and real-time patient level clinical and operational data reviews.  Senior Managers may be responsible for ensuring consistent implementation across programs and/or therapeutic areas.
Perform regular clinical and operational data reviews as described in CMP to identify, evaluate and report on emerging trends, meaningful data anomalies and detect potential fraud.
Develop and proactively monitor key quality and risk indicators to enhance study data quality, support data driven decision making and risk mitigation strategies.  Work with cross functional team to define appropriate thresholds and intervention strategies.
Support development of a global KQI/KRI library and performance metrics to identify studies that may require further escalation.  Senior Managers may be responsible for implementing program level or therapeutic area level performance metrics.
Design and implement appropriate tools, systems and processes to facilitate the conduct of review cycles, ensuring data integrity and quality (e.g. CSA and Spotfire).
Liaise with Medical Monitoring, Clinical Operations, and Data Management teams (and any other relevant functions) to develop study specific technology dashboard to facilitate any required cross functional review.
Contribute and/or lead departmental process or innovation initiatives as assigned.  Senior managers are expected to lead more complex or significant initiatives commensurate to their levels.

 

 

Qualifications

Education and Knowledge Requirements:

7+ years of professional related experience with understanding of centralized, risk based monitoring strategy required.
Bachelors Degree or higher, or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education.

Strong and effective oral and written communication skills and interpersonal skills
Ability to manage multiple projects independently (program and therapeutic area level oversight for Senior Managers).
Ability to work in a virtual, global and multi-cultural environment.
Knowledge of at least one visualization tool (i.e. Spotfire).
Experience with computerized clincal data mangement systems.
Prior experience with RBM practices and strategies preferred.
Knowledge of regulatory and industry guidances preferred (e.g. ICH E6 R2, Transcelerate).
Professional accuracy, integrity, dedication and motivation.

Function
Project Management
Sub Function
RandD
Reports To
In process of validation
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Posted: 2020-01-09 Expires: 2020-03-11

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Manager, Centralized / Risk Based Monitoring

Teva Pharmaceuticals
West Chester, PA 19380

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