Study Start Up Manager

Role Overview

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs
• Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to deliver the agreed project scope in compliance with the RSU Management Plan
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies
• Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation

Requirements

• Bachelor's Degree Life sciences or related field
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Wellness programs
• Other benefits