Pharm-Olam International

  • Clinical Team Leader

    Job Locations US
    Job ID
    2018-1852
    Category
    PM - Clinical Team Leader
  • Overview

    About Pharm-Olam International:

     

    Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

    Summary:

     

    The Clinical Team Leader ("CTL”) provides leadership and management to the Clinical Research Associates (“CRAs”) and other clinical functional groups, in their day to day clinical trial activities, to include direct communication and interaction with investigative sites and team members on a global, multi-country or regional basis.  The CTL is responsible for managing the planning, implementation, and tracking of the clinical monitoring process.  The position requires an active role in developing the plan and monitoring of both resource allocation and clinical trial so that all aspects of the plan are in progress.  The CTL serves as a proactive member of the core project team, liaising closely with the Project Manager (“PM”) on all study-related issues.  The CTL will perform tasks with minimal supervision whilst assisting, mentoring and supporting the CRA teams.  The CTL may have direct line management responsibilities for CRAs.

    Responsibilities

    • Manage the study start up in collaboration with PM and Regulatory Lead.
    • Coordination and oversight of Critical documentation collection, maintenance and filing.
    • Preparing Monitoring Plan (forward to PM for review and approval in compliance with Pharm-Olam SOP 003-09); preparation and oversight on Filing Plan as per Pharm-Olam SOP 003-06.
    • Modifying visit reports according study specific requirements.
    • Selection of investigators and sites; SEV report review and approval.
    • Site initiation management; SIV report review and approval
    • Monitoring Visit Report (“MVR”) review, management, resolution and escalation.
    • Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM.
    • Coordinate and manage site visit schedules.
    • Develop patient recruitment and retention plans.
    • Review and approves WTS time reporting.
    • Completing clinical part of Project Review Form and provide information about planned activities to PM to complete the Progression Charts.
    • Manages CRA site assignments and schedules.
    • Conducts project co-monitoring, assessment visits and team training.
    • Site contact for protocol clarifications and subject enrolment if CRA unavailable.
    • Protocol deviation documentation, tracking and escalation.
    • Oversees the development of study newsletters communication.
    • Relays project status and issues to PM.
    • Ensures appropriate CRA staffing and resources. Requests additional CRAs/CTAs and removes CRAs/CTAs through planned attrition according to project status.
    • Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise.
    • Oversight of CTMS updates.
    • Coaches/mentors CRA team.
    • Develops project-specific training materials for team.
    • Ensures project consistency within and across projects by following Pharm-Olam SOPs.
    • Assists and supports in the preparation of study specific training matrix and various training material used by Pharm-Olam (including SOPs training, as well as specific-therapeutic area related).  Assists and supports web based training material preparation.  Assists when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators’ meetings and other committees’ meetings as requested.
    • Manages Investigator and Site Payments.
    • May provide line management to CRAs (Europe).
    • May be assigned to monitor 1-2 sites.

    Working Relationships:

     

    • Reports to Senior Clinical Research Manager, Clinical Operations Manager, or designee.
    • Collaborates with Project Management, Clinical Research Managers, QA and other Pharm-Olam departments.
    • Liaises with clients as requested by the PM.

    Qualifications

    • A degree in life sciences or nursing qualification preferred, but not required
    • A minimum of 6 years clinical research experience with at least 1 year Lead CRA or other relevant team leadership experience
    • Ability to mentor and train other CRAs in a positive and effective manner
    • Ability to travel, on average 20-30% or less.
    • In-depth knowledge of clinical trials and the critical elements for success in clinical trials
    • Strong therapeutic background
    • Possesses experience and knowledge in the CRO industry that will support Pharm-Olam’s management of clinical trials
    • Demonstrates the ability to successfully manage people/project issues
    • Mature management skills demonstrated by calm and thorough review of situations.  Proactively identifies and addresses problems.  Seeks to understand all contributing factors.  Proposes, implements, and evaluates appropriate resolutions.
    • Demonstrates the ability to define and meet project requirements
    • Demonstrates flexibility for improvement and creating solutions
    • Proven organizational abilities, and excellent written and oral communication skills
    • Excellent team player with team building skills
    • Strong customer focus

    For Consideration

     

    Please apply online at www.pharm-olam.com/careers

     

    Pharm-Olam International, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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