Regulatory & Start Up Manager

IQVIA; Riyadh; On-site; SAR 180,000 - 240,000; Full time

Job summary

A leading global healthcare company in Saudi Arabia is seeking a Site Activation Manager to manage all aspects of site activation, maintenance, and regulatory activities for clinical studies. The ideal candidate will have 7 years of relevant experience and a Bachelor's degree in Life Sciences, with strong regulatory and technical writing skills. Proficiency in Arabic is essential. This role includes developing management plans, ensuring compliance, and mentoring team members.

Qualifications

• 7 years' relevant experience in a scientific or clinical environment.
• Strong understanding of regulated clinical trial environment.
• In-depth knowledge of drug development process.

Responsibilities

• Oversee Site Activation and Maintenance for assigned projects.
• Develop and maintain the Management Plan according to Scope of Work.
• Ensure collaboration across regions and countries.
• Create and review documentation to support business development.
• Mentor and coach colleagues as required.

Skills

Regulatory experience

Financial experience

Arabic language fluency

Education

Bachelor's Degree in Life Sciences or related field

Job description

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. This role requires a candidate strong in regulatory experience with finance experience as a benefit. Arabic language fluency.

Responsibilities

• 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

• Bachelor's Degree Life sciences or related field. 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
• 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