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2018-44547

2018-44547

Title 
Manager of Monitoring (MOM) - Manager of CLMs - Home Based
Job Locations 
-
US-Remote
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 Country Lead Monitors, 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.

Responsibilities

What will you be doing?

 

As a Manager of Country Lead Monitors, you are responsile for:

 

  • Directly manages 8-12 insourced staff combined of Country Lead Monitors, Sr Cllinical Research Associates and Clinical Research Associates. Assures hiring, training, development, and compensation are in line with talent and job expectations. Through effective management and oversight of direct reports, the Manager of Monitoring ensures quality and compliance as well as ensuring country’s objectives are met.  Provides expertise and strong leadership and management to insourced staff and maintains a motivated and competent staff, embedded into the Global Site Management country organization.
  • Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned insourced staff. These activities are done in close alignment with Country Head and peers.
  • Accountable for all operational activities related to global and country procedures applied in the site management of applicable Phase I and all Phase II-IV clinical trials. This includes country feasibility, site selection, site initiation, patient enrollment and data cleaning processes assigned insourced staff is responsible for. The GSM Manager of Monitoring assures that each assigned staff member delivers high quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards.
  • Responsible for managing costs associated with assigned insourced staff and participates in the Country Head of Site Management’s preparation and tracking of the insourced budget. Responsible for tracking insourced costs appropriately and provides estimates and accruals to Country Head on a monthly basis.
  • Quality Oversight - Oversees Corrective Actions / Preventive Actions (CAPAs) of assigned insourced staff to ensure timely and sufficient resolution. Conducts Monitoring Oversight Visits for each Site Manager as GSM expectations to ensure Site Managers are trained appropriately and to identify potential training or development needs. Participates in Audit Review Meetings and reviews all responses to audit findings prior to submission. Collaborates effectively with vendors providing insourced resources to develop and implement training and development plan in a timely manner based on any deficiencies found or areas for improvement.
  • Continuously and proactively identifies and proposes solutions for process improvement opportunities to Country Head GSM, and communicates best practices to entire monitoring staff. Participates as member of Expert Working Groups and provides feedback on SOP updates.
  • Coordinates responses of audits with Global Quality Management. Proactively identifies actions to be taken at the country level to improve upon audit and inspection findings. Supports Country Head with follow-up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP and the veracity of all clinical data in NDA, CTD, PLA, SNDA and IND submissions.
  • Contributes to delivering Training programs developed by GCDO ICH-GCP Training as well as coordinating all job-specific training needs for insourced CLMs, Sr Site managers, and Site managers. Requires thorough understanding of global and local processes, Global Drug Development and associated Global Standard Operating procedures (SOPs).
  • Contributes to development of country clinical investigator network to support the portfolio needs for clinical trials. Collaborates with Medical Science Liaison management to cultivate and enhance clinical investigator relationships to support business strategy

 

Qualifications

What do you need to have?

 

Education:      BS is required.

  • Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required
  • Substantial clinical trials development experience is required
  • Experience supervising or managing professional staff in a clinical research environment required
  • 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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