FSP Sponsor Dedicated Study Start Up Manager

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

Bachelors Degree Life sciences or related field Req

7 years relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education training and experience.

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

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $74600.00 - $216000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and / or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and / or other forms of compensation may be offered in addition to a range of health and welfare and / or other benefits.

Required Experience :

Manager

Key Skills

Restaurant Experience,Customer Service,Employee Evaluation,Management Experience,Math,Employment & Labor Law,Sanitation,Leadership Experience,P&L Management,Mentoring,Supervising Experience,Restaurant Management

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 74600 - 216000