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EDS Clinical Team Manager job

PRA Health Sciences jobs

Company

Salary

Skills

Company Description

The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs. More than anything else, our story would be about people. Not only our over 15,000 employees operating in more than 85 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.

Job Description

Responsibilities

The Clinical Team Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CTM leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted ccountabilities may or may not apply.

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
  • Performs any other duties required to ensure the success of the trial and/or PRA
  • Qualifications

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; alicensed health-care professional (i.e., registered nurse); or equivalent work experience required.
  • 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
  • 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
  • Read, write and speak fluent English; fluent in host country language required.
  • Estimated annual salary
    $80,478
    average
    Minimum
    $63,669
    Maximum
    $150,565

    TASKS

    • Develop and maintain computerized record management systems to store and process data, such as personnel activities and information, and to produce reports.
    • Direct, supervise and evaluate work activities of medical, nursing, technical, clerical, service, maintenance, and other personnel.
    • Direct or conduct recruitment, hiring, and training of personnel.
    • Develop and implement organizational policies and procedures for the facility or medical unit.

    SKILLS

    • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
    • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
    • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
    • SpeakingTalking to others to convey information effectively.

    KNOWLEDGE

    • Administration and ManagementKnowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
    • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
    • Economics and AccountingKnowledge of economic and accounting principles and practices, the financial markets, banking and the analysis and reporting of financial data.
    • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.

    PRA Health Sciences

    Type

    Company - Public

    Size

    10000+

    Revenue

    $100M to $500M

    Location

    Raleigh, NC,

    Industry

    Pharmaceutical/Bio-tech

    Founded

    1976

    CEO

    Colin Shannon

    Job Filters

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