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Clinical Trial Manager

Northbrook, IL 60062

Posted: 04/02/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 603732 Is job remote?: Yes Country: United States

Job Description


Pay 64-84 depending on experience

Purpose & Scope:

This position is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.

Essential Job Responsibilities:
  • Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Leads or supports cross-functional trial teams, including vendors
  • Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
  • Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
  • Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
  • Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
  • Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
  • Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
  • Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
  • Provide oversight and direction to trial team members for trial deliverables
  • Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
  • Ensure quality and completeness of TMF for assigned clinical trials
  • Participates in inspection readiness activities including coordination of clinical trial team deliverables
  • Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable

Quantitative Dimensions:

Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities

Organizational Context:

Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables

Qualifications:

Required
  • BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience
  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
  • Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
  • Requires project management skills and trial leadership ability
  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
  • Fluent in English
  • Moderate (~25%) travel required

Preferred
  • Advanced Degree

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Northbrook, IL

Ready to launch your career in the vibrant Northbrook, Illinois area? The opportunities here are as diverse as they are exciting! Nestled in the heart of Cook County, Northbrook offers a unique blend of urban amenities and suburban charm. Enjoy easy access to renowned attractions like the Chicago Botanic Garden, Allstate Arena, and Ravinia Festival, where music and culture thrive. Immerse yourself in the local scene with a wide array of culinary delights, from deep-dish pizza to gourmet dining experiences. With top-notch galleries, theaters like the North Shore Center for the Performing Arts, and professional sports teams like the Chicago Bears and Blackhawks just a short drive away, there's never a dull moment in Northbrook. Embrace a career in this dynamic region and unlock endless possibilities for professional growth and personal fulfillment. Explore our job listings today and take your career to new heights!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.