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Job

Clinical Trial Manager

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Caroline Candela

  • Contact email:

    c.candela@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2021-08-11

  • Startdate:

    ASAP

Our client partner is a clinical-stage biotechnology company focused on translating drug discovery and research into new treatments for patients. Our client is advancing their novel pipeline to treat metabolic and endocrine rare diseases and disorders.

 

Our client has one of the most innovative and exciting pipeline/programs in the industry which fuels their ambition to make great strides in the fight against metabolic and endocrine diseases.

Job Summary:

Our client is seeking a talented Clinical Trial Manager to join their clinical team. The ideal candidate will have a passion for novel science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs. They are looking for somebody with deep hepatology experience, but will consider all qualified and highly motivated candidates who want to roll up their sleeves and help our team with their clinical trial!

Job Responsibilities:

  • Overall management and coordination of clinical trials from startup to closeout
  • Coordinate country cross functional teams and act as the main point of contact for study team members
  • Work with team to select and manage CROs and other consultants and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH)
  • Work with Management to negotiate contracts and budgets with investigational sites and other vendors
  • Assist in generation and update of Clinical Development Plan (CDP)
  • Oversee study timelines and clinical trial budgets with finance group
  • Ensure timely and accurate documentation and communication of study progress and issue escalation as needed
  • Prepare and present materials for Site Initiation Visits
  • Investigator Meeting participation and preparation
  • May perform site closure activities, including post-close out
  • May act as point of contact for Sites
  • Participate in study team meetings and update project management on a weekly basis of study timelines and activities
  • Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports and other key operational/regulatory documents
  • Ensure compliance with study protocols, federal and local regulations and standard operating procedures (SOPs) and GCPs
  • Coordinate, develop and write the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for audit level findings. Drives CAPA review, implementation and completion •
  • Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of Clinical Operations
  • Working knowledge of CTMS, eTMF and EDC systems • Lead problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder(s)
  • Ability to mentor, train and/or educate junior, or new employees • Participate in the review and update of existing procedures and develop new procedures as needed • Perform other related duties as required to support Clinical Operations

Requirements:

  • Bachelors degree in scientific or medical discipline and 10-15 years work experience in the clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience
  • Familiarity with the life-cycle of a clinical trial Phase I to Phase III: from protocol development and feasibility through study close-out and reporting
  • Must have experience managing multiple vendors/contractors
  • Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule
  • Ability to get along well with different personalities and to work well in teams
  • Excellent written and oral communication skills, as well as conflict management, time management and organizational skills
  • Hepatology experience is highly preferred