IQVIA Site Activation Manager Job For BSc Life Sciences, Apply Online

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

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If are you looking for some interview questions for the Site Activation Manager only at IQVIA, then check the bottom of the page.

1. Question: Can you describe your experience in leading and managing site activation activities for clinical trials? Answer: Yes, I have been involved in leading site activation activities for the past five years, with two years of experience in a leadership role. During this time, I have successfully executed strategic planning, project oversight, and accelerated site activation for patient enrollment. I have managed multiple regions and ensured adherence to regulatory requirements and internal policies.
2. Question: How do you ensure compliance with regulatory requirements, such as International Conference on Harmonization-Good Clinical Practice (ICH-GCP), during the site activation process? Answer: Ensuring compliance with regulatory requirements is a critical aspect of site activation. I have a strong understanding of ICH-GCP guidelines and other relevant regulations. I develop and implement Site Activation Management Plans that align with the project strategy and regulatory expectations. I also closely monitor the regulatory landscape, collect regulatory intelligence, and offer practical solutions to address any challenges.
3. Question: How do you effectively communicate and collaborate with internal and external stakeholders during the site activation process? Answer: Communication and collaboration are key to successful site activation. I maintain open and proactive communication with key stakeholders, including regions, countries, and sponsors. I resolve project-related issues and ensure effective resolution management. I also contribute to the development of strong relationships with preferred customers, attending meetings and providing support throughout the study.
4. Question: Can you provide an example of a complex site activation project you have managed and how you overcame challenges? Answer: Certainly. In a recent project, we faced challenges related to regulatory submissions and obtaining necessary authorizations. To overcome these challenges, I conducted a thorough assessment of the regulatory landscape, developed a clear regulatory strategy, and offered creative solutions. By collaborating closely with internal and external stakeholders, we successfully obtained the required approvals and authorizations, ensuring the project stayed on track.
5. Question: How do you ensure accuracy and compliance with timelines, tracking tools, and project plans during site activation? Answer: Accuracy and adherence to timelines are critical for successful site activation. I maintain meticulous attention to detail and ensure accurate completion and maintenance of internal systems, databases, tracking tools, and project plans. I review technical and administrative documentation, contribute to business development efforts, and mentor colleagues to maintain high-quality standards throughout the trial period.

Remember to tailor your answers to your specific experience and highlight relevant achievements in the field of site activation management. Good luck with your interview!