Responsible for delivery and/or may manage a team of employees responsible for executing site activation activities that may include:

· Site identification and feasibility activities, Regulatory, start-up, and maintenance activities
· Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors
· Maintains, reviews, and reports on site activation performance metrics
· Serves as the primary point of contact for investigative sites and/or sponsors; 
· Ensures tracking completion of all regulatory and contractual documents for sites 
· Establishes project timelines.
· Ensures all site activation activities are performed in accordance with all regulations, SOPs, Work Instructions and project requirements either at the global, regional, or country level and all relevant documents are submitted timely to the Trial Master File as per IQVIA/Sponsor requirements.
· Establishes and/or executes goals and objectives for team(s) as well as tracking and delivering on operational/financial performance.
· Participates in the broader Global Site Activation planning process; contributes to long-mid range goals and plans; and coordinates activities with other managers and their respective sub-families.

Additional FSP Client Specific Responsibilities, may include: 
* responsible at country level for providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management
* support country oversight of the Master clinical study agreement, single clinical study agreement and applicable amendments and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets for assigned studies.
*ensure clinical study agreement execution prior to site activation deliverables within the timelines and in an efficient manner
*serve as central point for escalation of all legal, contract language and budget escalations
*Drive a consistent and effective operating model to standardize the Master and Clinical Study Agreements (CSAs) and Budget
*Demonstrate accurate knowledge of regulations and policies in order to be able to maintain and develop the effectiveness of Clinical Study Agreements
*Improve to the development and execution process of contracts and budgets, in collaboration with local and global teams
*Demonstrate a strong understanding of how the contracting process and budget contributes to PMCO (schedule/cost forecasting and risk management)
*Coordinate budget escalation approvals with relevant stakeholders
*Act as point of contact and interface with Legal if necessary to ensure contract integrity
* Lead preparation and delivery of study documents related to CSA and payments
*Build a partnership with site contract and budget team, and lead remote site discussions to resolve and finalize contracts in an expedited manner
*Attend and engage in scheduled study team meetings
*Share information (metrics) on site progress towards the activation within local study teams and Senior Management as required

Requirements: 
•  Bachelor degree required, preferably in life science, law, finance or equivalent qualification or experience.
•  Four or more years of experience in the pharmaceutical industry working with delivery of clinical studies
•  Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
•  Good knowledge of relevant local regulations
•  Good collaboration, negotiation, and interpersonal skills.
•  Excellent attention to details.
•  Excellent written and verbal communication skills.
•  Comprehensive knowledge of the drug development process.
•  Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
• Good understanding of Clinical Trial processes including start up, monitoring, study drug handling and data management.
•  Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $108,500.00 - $162,750.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.