PRAHS

2017-42571

- | US-Remote
1 month ago
Title
Clinical Team Manager - Multiple Levels

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 13,000+ 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 leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. 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 Clinical Team Manager (CTM), you have a wide range of responsibilities. We’re including a few of the big ones. Primarily, you will work to achieve the most successful clinical trial possible. You will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. You will proactively identify, resolve/mitigate, and escalate risks or issues when necessary.

 

Job Responsibilities:

  • Provides Project Oversight and Leadership for Clinical Deliverables:
    • Leads and manages the start-up and clinical teams
    • Plans and leads execution of the day to day activities for the monitoring of a clinical study and
    • communicates consistently with the clinical team providing project objectives, expectations and status updates
    • Works with the team to set priorities
    • Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters
    • Motivates the clinical team
    • Ensures effective communication plans are place for the clinical team
    • Ensures effective escalation plans are in place for the clinical team
    • Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study
    • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
    • Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues
    • Identifies opportunities to improve training, execution and quality control across the team
    • Liaises with relevant staff to provide data as required for clinical operations performance metrics and project status metrics
    • Works with the relevant staffto identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
    • Attends Executive Project Status Reviews as required
  • Project Resourcing
    • Works with the relevant staff (including Director of Project Delivery (DPD) when applicable) to ensure all Clinical team members are adequately assigned to the project
    • Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activities throughout the project duration
    • Actively monitors initial and ongoing clinical resource and identifies/escalates issues to the Project Manager (PM) and/or Clinical Management when applicable
    • Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
    • Disseminates and agrees forecasted activities/FTE to all key team members
    • Oversees transition plans to allow seamless transition of knowledge in case of CTM or clinical team member replacement
  • Quality – Training & Development
    • Creates and maintains project specific plans, documents and tools for the clinical team
    • Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinical project specifics
    • Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies. Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
    • Ensures all PRA project reporting systems are up to date for clinical activities at the project level
    • Oversees the CSS, GRAL, LRAL and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
    • Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
    • Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution
    • Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems
    • Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
  • Project Finance
    • Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM)
    • Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget
    • Ensures that forecasted units are achieved as planned and within the budgeted FTE
    • Identifies out-of-scope tasks from clinical team and escalates as required
    • Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff
  • Customer Relations (Internal & External)
    • Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved
    • Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required
    • Participates in client meetings, assisting with presentations as required
    • Contributes to Business Development activities participating in proposals and bid defenses as needed

Qualifications

What do you need to have?

 

Level 2 Qualifications

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (ie, registered nurse); or equivalent work experience, required
  • 5+ years of clinical research experience required, including at least 2 years’ experience in clinical trial management, required
    • 2+ years monitoring experience, preferred
  • Experience in managing all trial components (start-up to database lock), preferred
  • Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
  • English fluency (ability to read, write, speak), required
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

 

Level 3 Qualifications

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (ie, registered nurse); or equivalent work experience, required
  • 7+ years of clinical research experience required, including at least 4 years’ experience in clinical trial management, required
    • 2+ years monitoring experience, preferred
    • Experience in managing complex or global trials, preferred
  • Experience in managing all trial components (start-up to database lock), preferred
  • Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
  • English fluency (ability to read, write, speak), required
  • Travel of up to 35% is required for this position.
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

 

LOCATION: This is a home-based position. Consideration will be given to candidates in the US and Canada.

 

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

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