Site Activation Manager
Site Activation Manager
(Project Manager of Start up of a Clinical Trial )
Job Family Description
Functional leader with operational support to the Clinical Research organization to ensure the well-being of clinical research subjects and the best possible project outcomes.
Project manager for the start-up phase in charge of design and implementation of the strategy towards site activation from award until open to enrollment. Lead and oversee the country operations teams ensuring client commitments are delivered timely and according to project scope and processes.
Job Profile Summary
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.
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 Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope.
Create and/or review technical and administrative documentation to support business development and enable study activation and maintenance, as required.
Provide technical and 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 site activation.
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 and 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.
Minimum Required Knowledge, Skills and Abilities
B Sc Degree in Life Sciences or related field
Proven experience managing projects in a scientific or clinical environment(desirable). Experience in an international environment preferred.
Requires experience in leading projects in a cross-functional team.
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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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