Job Overview

Direct and manage the execution of the strategic, operational and financial delivery of revised clinical study documents and regulatory activities included but not limited to participation in revised clinical study documents meetings, Ethics and Regulatory processes, Site Contracting and implementation of revised clinical study documents for assigned studies as determined by Company, scope of work and oversight of the scope of work and/or sponsor requirements.

Essential Functions
- Provides strategic planning and project oversight accelerating implementation of revised clinical study documents through best in class project management to ensure rapid implementation
- Support and/or participate in pre-award/bid defense activities, for transitioned studies from other CROs/Pharma
- Oversee the execution of Lifecycle Maintenance for assigned projects in accordance with the agreed strategy, adhering to agreed project timelines and in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol,



customer requirements, and internal policies.
- Study Delivery Scope minimum expectations: accountable for high size and medium complexity studies
- Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Site Activation Management Plan.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemina

📌 Maintenance Lead (Thane)
🏢 Iqvia Biotech
📍 Thane