Site Activation Manager
IQVIA is looking to appoint a Site Activation Manager to support a good surge of studies. You will manage and execute the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.
Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of regulatory and contractual documents for sites; ensures contracts are fully executed; and establishes project timelines.
- Serve as Site Start-Up lead within Asia Pacific region for projects & lead RSU team in all designated activities.
- Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
- Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
- Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
- Work with Quality Management to ensure appropriate quality standards for the duration of the project.
- 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 proactive role in developing long standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- Bachelor's Degree Life sciences or related field
- 5 years of regional experience in clinical research environment, ideally regulatory and study start-up capacity
- 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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