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Company Overview

The Bartech Group is a professional services firm that provides human capital solutions. Bartech provides several key services:

  • Contingent Workforce Solutions
  • Recruitment Process Outsourcing
  • Search Services
  • Staffing Services
  • Business Process Outsourcing/Consulting
Each of these services is designed to improve productivity, manage costs and increase the quality of our client workforces. Our strength is our ability to both design and deliver effective solutions that help our clients meet key business objectives.



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Clinical Protocol Manager    Apply for this job now!
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Job Description

The Bartech Group, one of America's largest and fastest-growing staffing firms, continues to elevate the staffing industry to a higher level of thinking. Bartech Enterprise Staffing specializes in temporary and direct placement of Engineering, IT, Technical, Finance & Accounting, and Professional staff.

Currently we are seeking individuals for the following position:
Clinical Protocol Manager

Job Responsibilities:
CPM/Clinical Scientist is responsible for the delivery of multiple clinical studies from concept through reporting for early development programs from pre-clinical through Proof of Concept and then transition to a Business Unit or external collaboration.
The CPM/Clinical Scientist aligns the studies within a program in accordance with the overall program timeline, cost and quality goals.
This individual will report to BBC/BTx Clinical Operations Head and is responsible for study deliverables to the Study Clinician.

- Matrix leadership of the clinical Study Team(s)
- Leads the cross-functional integration of all components of a study by working with study team members for externally sourced studies to CROs or internally sourced studies to Development Operations (including but not limited to Study Managers, Project Planners, Clinical, Statistics, Pharmaceutical Sciences, Outcomes Research, Regulatory, Study Managers, Contracts & Outsourcing (C&O), Clinical Programmers, Medical Writers, Clinical QA) both internal and external (e.g., Functional Service Providers (FSPs), CRO) to ensure studies deliver to agreed goals.
- Deliver goals and coordinate the planning, initiation, completion and reporting of clinical studies from synopsis development to reporting. Ensure that individual clinical studies meet agreed time (including recruitment), quality & cost targets consistently.
- Contribute to and drive the development and endorsement of the study level plan with the clinical study team. Ensures that schedule, cost, resource management, study quality are established and maintained between clinical study activities and the overall development plan.
- Contribute to clinical protocol development via participation in protocol design meetings to ensure operational and scientific consequences are factored into design decisions and appropriately represented when synopsis is signed off / endorsed.
- Initiate and coordinate clinical study drug planning at the program level and requests for assigned studies.
- Translate the Development Plan goals into relevant, tangible and measurable goals for assigned studies. Ensure alignment across all disciplines of clinical study team required to deliver a study.
- Drives alignment of functions and vendors to deliver high quality and timely execution of study deliverables within cost targets and in compliance with the Development Plan and relevant regulatory requirements.





Job Requirements

Skills Required to be considered:
- At least 10 years of clinical operations in pharmaceutical industry in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
- Excellent knowledge and demonstrated experience in the project management discipline and its application to drug development
- Strong track record in leading operational execution of clinical studies to time, cost, and quality targets
- Effective communication and influencing skills are required in relating to customers and colleagues both inside and outside the organization.
- Knowledge of team development principles and successful implementation required.
- Experience supporting regulatory submissions a plus.
Demonstrated success in negotiating the environment of a highly matrix-based organization.
- Record of achievement and delivery for personal and team goals
- Opthamology experience a plus

Minimum Education Required:
- Minimum requirement: Bachelors degree or equivalent in one of the disciplines related to life sciences, drug development or business.
Advanced degree is desirable.
- Opthamology experience a plus

When you join The Bartech Group you launch a career. We support you with a comprehensive benefit plan, offering exceptional medical, dental, and vision care; life and disability insurance; paid time off including holidays; and 401K.

 

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