Clinical Trials Manager - Dechra Pharmaceuticals - Overland Park, KS | JobsInKS.com

Clinical Trials Manager

Dechra Pharmaceuticals | Overland Park, KS

Dechra Pharmaceuticals
The Employer has temporarily removed this posting

Job Purpose

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide. 

The primary function of the Clinical Trials Manager position is to coordinate and execute all aspects of Dechra’s clinical studies in support of global product registrations. The Clinical Trials Manager will ensure that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Technical Lead and are in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice).  The Clinical Trials Manager is supported by internal Study Monitors and Clinical Data Manager along with external contract resources as needed.

Key Responsibilities

  • Assist Efficacy Technical Leads in designing clinical studies
  • Create draft protocol (based on study outline from Efficacy Technical Lead) and facilitate protocol, review, submission for concurrence (if applicable), revision, and finalization
  • Collaborate with monitors to ensure appropriate study site selection, qualification, and training
  • Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable
  • Work with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studies
  • Create clinical study site budgets, oversee tracking of study spend, and approve study-related invoices
  • Establish contracts with clinical sites and other vendors
  • Work with Product Development Coordinator to organize clinical supply for studies
  • Oversight of study monitoring and review of key study data following site close-outs
  • May monitor clinical study sites on an as-needed basis
  • Update Efficacy Technical Leads on study status
  • Oversee data cleaning and database lock
  • Assist Efficacy Technical Leads in authorship of Final Study Reports
  • Provide technical and scientific support to members of the Product Development organization as needed
  • Work with the Senior Manager, Clinical Operations and Clinical Trials Managers on the creation and implementation of policies and SOPs related to clinical studies
  • Work with the Senior Manager, Clinical Operations and Clinical Trials Managers to implement new processes and technologies related to study execution and oversight
  • Assess resource needs for clinical studies and work with the Senior Manager, Clinical Operations and Clinical Trials Managers to determine appropriate allocation of internal and external resources

Competencies

Commercial and Business Acumen

GCP Experience

Relationship Management

Results Focused

Engagement

Problem Solving

Customer Service

Product and Technical Knowledge

Qualifications

College degree in relevant field

Knowledge and Experience

Minimum 5 years of experience in oversight of veterinary clinical field trials.  Strong monitoring background is preferable.

Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, and report writing

Strong analytical & organizational skills with the ability to handle multiple tasks and prioritize

Ability to communicate effectively with excellent written/verbal skills

Additional Details

Regular travel required

 

 

 


Posted On: 2018-01-15 13:48:30
Closing Date: Open Until Filled
Telecommute: No
Categories: Pharmaceutical, Science, Veterinary Services
Job Type: Regular
Job Status: Full Time
Minimum Degree: Bachelor's Degree
Pay Type: Annual Salary
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