Job Description

Reference # : 17-12431Title : Protocol Data Manager
Location : Princeton, NJ
Experience Level : Start Date / End Date : 01/02/2018 / 07/01/2018
Assignment Detail
Industry:Biotech/PharmaJob Category:Data Management
Description
Protocol Data Manager

Work for a global healthcare leader. Eclaro is looking for a Protocol Data Manager for our client in Princeton, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

The Protocol Data Manager is responsible for the remote assessment of Risk Indicators that identify issues and emerging risks in clinical trial study-specific variables (trends / outliers / poor performing sites) through the review of aggregate data. He/She is responsible for the review of clinical and operational data. The Protocol Data Manager will interact with HQ clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring (RBM) methodology being adopted by Client.

RESPONSIBILITIES:
  • Demonstrated ability to support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all TAs & phases of dev).
  • Use analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues & emerging risks at the study, program, country, TA and functional level, to ensure risks are addressed consistently.
  • Identify critical data issues & document findings for tracking and timely resolution.
  • Demonstrated ability to effectively communicate ideas/concepts to accomplish challenging shared goals and objectives.
  • Contribute to the development of and provide feedback on documented processes developed for RBM methodology being adopted by Client.
  • Provide user input on IT needs necessary to support all aspects of Risk Based Monitoring
  • Use of software independently and without assistance: Basic office tools (e.g. MS Suite); software and tools used for Central Monitoring activities (e.g. SAS, J-review, Spotfire).
  • Ability to contribute to the development of and provide feedback on training material developed to support RBM methodology.
  • Accountable for ensuring global inspection readiness in regards to RBM monitoring process and tactics.

QUALIFICATIONS:
  • Demonstrated knowledge of clinical operations, inclusive of site monitoring/site management and data management
  • Ability to contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness
  • 5+ years in drug development and 3+ years in the field of data management, programming, statistics, finance or related
PREFERRED:
  • Degree preferred in one of the following disciplines or related fields:
    • Life Sciences
    • Analytics
    • Data Science
    • Statistics
    • Informatics
    • Business
    • Finance

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying?
Contact Cheryl Buot at (212) 901-3840 or at www.linkedin.com/in/cheryl-buot-56ba4836 and/or send your resume to Cheryl.Buot@eclaro.com now.


Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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