Regional Site Activation Manager

2 weeks ago

Singapore IQVIA Full time

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.

**Key Responsibilities**:

- 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.

**Key Requirements**:

- 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
- 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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