Job Overview Direct and manage the execution of the strategic, operational and financial delivery of required Site Activation activities, including but not limited to Site ID and Selection, Ethics and Regulatory processes and Site Contracting for assigned studies as determined by Company, scope of work and/or sponsor requirements. Essential Functions ● Provides strategic planning and project oversight accelerating Site Activation through best in class project management to ensure fast site activation for patient enrollment, responsibilities may include; Accountable for multiple regions. ● Support and/or participate in pre-award/bid defense activities. ● Oversee the execution of Start Up (including pre-award through Site Activation) and/or Lifecycle Maintenance for assigned projects in accordance with the agreed start up 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 multiple regions or Global SAM project oversight responsibilities. ● 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 dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. ● 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 Management Plan. ● Provide ongoing updates and reporting to various levels of the organization, both study team and in some cases senior level colleagues. ● Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. ● Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. ● Adhere to quality standards, regulated and Company specific through the duration of the trial period. ● Deliver presentations/training to clients, colleagues and professional bodies, as required. ● Contribute to initiatives that affect positive change within the department and organization: support department and organizational initiatives.
