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operations

Posted 18 hours ago

Manager Clinical Operations II / Madison, WI (On-site)

at Fortrea

On-site

Responsibilities

  • Develop and maintain effective relationships with the management team to manage assigned staff in a matrix environment.
  • Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business. Other key
  • Hold staff accountable for quality and compliance with project plan and adherence to contract obligations.
  • Coach staff to own effective Investigation relations and Investigator oversight when applicable.
  • Report status of assigned workload of direct reports and ensure allocation reports are updated.
  • Perform weekly review of direct report billable hours and utilizations (in context of project allocation supply and demand); escalate of outliers and assists management team for mitigation.
  • Support the company/department processes (e.g., Quality Control Visits).
  • Identify, develop, and implement measures to improve the efficiency of the department.
  • Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented.

Requirements

  • As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking a Manager, Clinical Operations II, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment.
  • YOU NEED TO BRING… University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory). 5 years of direct Clinical research
  • experience (i.e., worked as a Clinical Team Leader/Project Manager at a Pharma or CRO). Individual proficiency with managing direct reports or equivalent combination of education and
  • experience to successfully perform the key responsibilities of the job.
  • Teamwork and people skills are essential for the study to run smoothly. Technology based .
  • Must have excellent command of the English language, both oral and written.
  • Must be able to use hands to finger, handle, or touch objects, tools or controls, including a computer keyboard, for up to 6 hours per day.

Benefits

  • Responsible for staff time management, PTO and salary reviews.
  • benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) Employee recognition awards Multiple ERG’s (employee resource groups) Physical

Additional details

  • Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.) This is a full-time, office/clinic-based job in Madison, WI .
  • If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.
  • Many are drawn to this profession because of its direct impact on patient care.
  • If this is your case, you will not miss that working in Phase 1 trials.
  • Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand.
  • When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.
  • WHAT YOU WILL DO: Responsible for the supervision of assigned direct reports within PI MS. Responsible for detailed performance review and management of assigned direct reports including Annual Performance Management and Development (PMD) and Individual Development Plan (IDP).
  • Responsible for appropriate management and resolution of performance issues.
  • Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams.
  • Escalate issues and follow them till proper resolution.

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