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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Data Manager

Job Description

  • Location: Princeton, NJ
  • Type: Contract
  • Job #74452

Our client, a leading pharmaceutical company, is hiring a Data Manager on a contract basis.

Work Location
Princeton, NJ

Summary

The CMN will interact with clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring methodology adopted by client

Position Responsibilities
Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of client programs and protocols.

Support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).

Utilize analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues and emerging risks at the study, program, country, therapeutic and functional level, to ensure risks are addressed consistently.

Identify critical data issues and document findings for tracking and timely resolution.

Contribute to the development of or provide feedback on documented processes developed for risk-based monitoring methodology being adopted by client.

Contribute to the development of or provide feedback on training material developed to support RBM methods.

Accountable for supporting global inspection readiness and inspections in regard to RBM monitoring process and tactics

Provide user input on IT needs necessary to support all aspects of RBM.
Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.

Acts as a change agent with stakeholders across R&D, including educating, bridging knowledge across functions and developing effective partnerships with critical stakeholders.

Degree Requirements
4 Year Degree required in one of the following disciplines or related field: Life Sciences; Analytics; Data
Science; Statistics; Business
Experience Requirements
3+ Years in drug development is preferred
3+ Years in the field of site management, site monitoring, data management or related is preferred

Key Competencies
Demonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging shared goals and objectives.

Well-versed in analytical and conceptual capabilities
Demonstrated ability to apply critical thinking and identify, distinguish relative importance and be able to work through issues remotely

Demonstrated knowledge of clinical operations, inclusive of site monitoring, management and data management

Demonstrated knowledge of Good Clinical Practices (GCP)
Demonstrated ability to absorb critical knowledge on relevant protocol/trial design requirements as well as relevant clinical/disease area knowledge

Demonstrated ability to successfully manage competing priorities to achieve the goals of the department and the larger organization.

Thorough knowledge of global regulatory and guideline (inclusive of ICH GCP) requirements with clinical experiences in a drug development capacity

Demonstrated ability to build and maintain strong relationships across organizational and/or geographic boundaries through participation on cross-functional teams.

This person will be part of the Centralized Monitoring group working as a Central Monitor within GDMCM. Job Description has the details for the Central Monitor role. The role is required to be in the office 50% over 2 weeks as per client Flexible Ways of Working.

 

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