PRAHS

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2018-44552

2018-44552

Title 
Manager of Clinical Support Coordinators (MCSC) - Whippany or Parsippany, NJ
Job Locations 
-
US-NJ
Posted Date 
1/9/2018

More information about this job

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

 

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Manager of Clinical Support Coordinators in Whippany, NJ or Parsippany, NJ, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

 

Still here? Good. Because if this is you, we’d really like to meet you.

 

What will you be doing?

Responsibilities

As a Manager of Clinical Support Coordinators in Whippany, NJ or Parsippany, NJ, you are responsile for:

 

  • Supervise study administrative personnel (Clinical Support, Clinical Records Coordinators and Administrative Staff) in their day to day work.
  • Establish clear direction and performance targets.
  • Attract and retain high performers. Build skills and knowledge of direct line reports. Coach, mentor, review progress, manage development needs and ensure that direct reports receive required training.
  • Drive the coordination and deployment of resources for global projects e.g. personnel exchanges to support career development or to support specific studies.
  • Implement best practices and ensure quality management for study administrative support and records coordination.
  • Evaluate audit findings to improve quality and consistency across in the Clinical Support and Records Coordination group.
  • Allocate resources to maximize efficiency and effectiveness based on priorities cascaded by the Head of Monitoring in line with corporate and Global Monitoring and Study Management strategy.
  • Match skills and capabilities of staff appropriately with the needs of the studies.
  • Oversee the records management processes and procedures for clinical trials which includes the indexing, filing, retrieval, storage, security, photocopying, scanning, microfilming and archiving of all
  • paper and electronic documents (e.g. paper, optical, electronic, film, CD-ROM). Ensure stringent quality control procedures to maintain the integrity, completeness and security of confidential information.
  • Administer and monitor the regional clinical trial records retention program to ensure full life cycle retention, maintenance and disposition in compliance with global standards and procedures, legal
  • requirements and regulatory guidelines.
  • Provides assistance with coordinating critical components of the NDA, including QA review of electronic document links for submissions.
  • Assures US Monitoring & Study Management objectives are met by monitoring key performance indicators as well as US Department objectives while tracking progress, efficiencies and cost effectiveness.
  • Identifies process improvement opportunities, share best practices to continuously improve work processes and eliminate redundancies.
  • Ensure compliance of staff with all relevant SOP’s, GCP and ICH guidelines, as well as with legal and ethical standards.
  • Partner with Managers and Study Managers to ensure Contract Research Organizations (CRO’s) are adhering to ICH and local requirements.
  • Perform budget forecasting. Assist with reconciling, tracking and maintenance of department’s cost center budget of approximately $8M.
  • Assure that billing and payments are coded and charged accurately.
  • Work with controlling and financial accounting to reconcile discrepancies found in SAP.
  • Assist VP/Global Head of Study Management with cost analysis as needed.
  • To ensure that expected quality goals are met, facilitate training and supervision of external study team members contributing to clinical support coordination and records coordination.

Qualifications

What do you need to have?

 

Education:      BS is required.

Skills: 

  • Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required
  • Substantial clinical trials development experience is required
  • Appropriate direct line management experience Of Clinical operations staff
  • Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required.
  • Read, write, and speak fluent English; fluent in host country language required.
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required.
  • Advanced degree, or its international equivalent, preferred



PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

 

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