Site Activation Manager

IQVIA Inc; Durham (NC); On-site; USD 87,000 - 216,000; Full time

Job summary

IQVIA Inc is seeking an experienced Site Activation Leader to direct the strategic, operational and financial execution of activation activities for assigned studies. You will oversee Site ID/Selection, Ethics and Regulatory processes, site contracting, and cross-regional project delivery.

You will drive the start-up lifecycle, coordinate with stakeholders, and ensure adherence to timelines and regulatory requirements (ICH-GCP). Strong leadership and global experience are essential.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• At least 5 years with 2 years of lead experience in a scientific or clinical environment required.
• Demonstrable experience in an international role or equivalent combination of education, training and experience required.

Responsibilities

• Direct and manage the execution of Site Activation activities including Site ID/Selection, Ethics and Regulatory processes and Site Contracting.
• Provide strategic planning and project oversight to accelerate activation and enrollment across multiple regions.
• Oversee Start Up lifecycle maintenance for assigned projects ensuring timelines and regulatory compliance.
• Collaborate with internal and external stakeholders to deliver the project scope per Site Activation Plan.
• Develop and maintain Site Activation Management Plan and related documentation.
• Monitor regulatory landscape and provide regulatory intelligence to support studies and bid processes.
• Provide updates to study teams and senior leadership as required.

Skills

Project management

Global/international experience

Leadership experience

Education

Bachelor's degree Life Sciences

Job description

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.
• Mentor and coach colleagues as required: mentor to Grade 140.
• May take a lead role in developing long standing relationships with preferred IQVIA customers: Maintain and develop the customer relationship through study teamwork and support providing input to customer level processes and/or initiatives , attend Early Engagement Customer or Partnership Meetings if required.
• 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.

Qualifications

• Bachelor's Degree Life sciences or related field Req
• At least 5 years with 2 years of lead experience in a scientific or clinical environment. Req
• Demonstrable experience in an international role; or equivalent combination of education, training and experience. Req

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $86,500.00 - $216,000.00. 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.