Study Start Up Lead

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Ensure all startup activities for projects are performed on-time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements • Together with the study Project Manager, manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan • May oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites liaison • Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached • Responsible of coordinating EC/IRB submissions or any other notification requested as well as coordination with Regulatory department regarding HA/CA submissions/notification • Ensure and oversight the proper adaptation of Subject Information and Informed Consent documents according to local law and requirements • Coordinate site evaluation and feasibility process for assigned projects • Ensure all Start Up documentation is submitted properly and on time to the Trial master File • Assist the Project Manager ensuring the Project is properly set up in CTMS and all information related to start up activities is properly updated

🎯 Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent • Minimum 4 years of experience in any relevant Clinical Operations experience related to Start Up procedures • Able to work in a fast-paced environment with changing priorities • Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas • Possess the understanding of Good Clinical Practice regulations, ICH guidelines • Ability to work independently as well as in a team matrix organization and multiple projects • Excellent written and verbal communication skills as well as computer skills • Excellent organizational and Line Management skills • Ability and willingness to travel up to 10-20%

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth in a rewarding environment • Collaboration, innovation, and making a difference in the lives of patients