Regulatory and Start Up Manager, MedTech, Poland

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee the execution of Site Activation (including pre-award/bid defense activities) 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 successfully 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, as required.

• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.

• 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 and wider company, as required.

• 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 (or Maintenance, as applicable).

• Mentor and coach colleagues as required.

• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

• May take a lead role in developing long standing relationships with preferred IQVIA customers.

• Deliver presentations/training to clients, colleagues and professional bodies, as required.

• May be involved in activities related to monthly study budget planning and reviews.

Qualifications and Skills

• Bachelor's Degree Life sciences or related field

• 7 years' relevant experience in a scientific or clinical environment including demonstrable experience in a global role

• Polish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees

• 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

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