IQVIA
StudyStartUpManager(SSUM)
Neural analysis suggests this role is
optimal for Manager candidates.
“Study Start Up Manager (SSUM) at IQVIA. Skills: Site activation, Regulatory affairs, Clinical trials. Direct delivery of site activation activities. Manage site activation activities”
Industry & Context.
Resolve project related issues; Identify regulatory challenges; Offer practical solutions; Exercise independent judgment; Taking calculated risks
What They're Looking For.
Must Have
Bachelor's Degree Life sciences, 7 years relevant experience, Experience in a scientific or clinical environment, Demonstrable experience in an international role, Thorough understanding of regulated clinical trial environment, In-depth knowledge of drug development process, Proficiency in using systems and technology, Good regulatory writing skills, Good technical writing skills, Knowledge of GCP guidelines, Knowledge of ICH guidelines, Ability to apply applicable regulatory guidelines, Good leadership skills, Ability to motivate, Ability to coach, Ability to mentor, Ability to exercise independent judgment, Ability to take calculated risks, Excellent understanding of study financial management, Proven ability to work on multiple projects, Proven ability balancing competing priorities
What You'll Do.
Direct delivery of site activation activities
Manage site activation activities
Manage regulatory activities
Oversee site activation execution
Oversee maintenance activities
Develop Management Plan
Implement Management Plan
Maintain Management Plan
Resolve project related issues
Ensure collaboration across Regulatory & Site Activation
Communicate with regions and countries
Create technical documentation
Review technical documentation
Create administrative documentation
Review administrative documentation
Provide specialist regulatory support
Provide specialist technical scientific support
Facilitate business development
Facilitate study initiation
Facilitate study maintenance
Provide overall guidance
Provide oversight of multi-regional programs
Provide oversight of multi-protocol programs
Determine regulatory strategy
Determine regulatory expectations
Determine parameters for submissions
Determine parameters for authorizations
Identify regulatory complexity
Identify regulatory challenges
Offer creative solutions
Offer practical solutions
Support execution of site activation plan
Assess regulatory landscape
Review regulatory landscape
Contribute to collection of regulatory intelligence
Contribute to interpretation of regulatory intelligence
Contribute to analysis of regulatory intelligence
Contribute to dissemination of regulatory intelligence
Execute operational strategy
Execute operational expectations
Maintain clinical study approvals
Maintain clinical study authorizations
Review essential documents
Negotiate essential documents
Work with Quality Management
Ensure appropriate quality standards
Ensure accurate completion of internal systems
Ensure maintenance of internal systems
Ensure accurate completion of databases
Ensure maintenance of databases
Ensure accurate completion of tracking tools
Ensure maintenance of tracking tools
Ensure accurate completion of timelines
Ensure maintenance of timelines
Ensure accurate completion of project plans
Ensure maintenance of project plans
Take lead role in developing relationships
Deliver presentations to clients
Deliver presentations to colleagues
Deliver presentations to professional bodies
Deliver training to clients
Deliver training to colleagues
Deliver training to professional bodies
Involved in monthly study budget planning
Involved in monthly study budget reviews
How You'll Work.
Team & Collaboration
Collaboration across Regulatory & Site Activation; Communication with regions and countries; Integral member of study management team; Work with Quality Management; Develop relationships with customers
Communication Scope
Technical writing; Regulatory writing; Presentations; Training
Process & Methodology
Scope of work, Project plan, Project strategy, Project execution, Project plans
Full Job Description
_**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 m
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