IQVIA Hiring BSc Life Science For Site Activation Job – Apply Online

IQVIA Hiring BSc Life Science for Site Activation Job 

IQVIA Hiring BSc Life Science for Site Activation Manager Job. Interested candidates check out the details below and Apply Online.

Job title: Site Activation Manager

Job Location: Thane, Maharashtra, India

Job id: R1362307

Job Type: Full Time

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

APPLY ONLINE

IQVIA Hiring BSc Life Science for Site Activation Job. Here are Possible interview questions and answers:

1. Question: How do you ensure efficient and timely site activation for patient enrollment in clinical studies while adhering to regulatory requirements and internal policies? Answer: As a Site Activation Manager, I believe in leveraging best-in-class project management practices to accelerate site activation. By developing a robust Site Activation Management Plan in line with the project strategy, I ensure that all start-up activities, including site ID and selection, ethics and regulatory processes, and site contracting, are executed promptly and in compliance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and other relevant regulations. I collaborate closely with both internal and external stakeholders, resolving issues proactively to maintain agreed project timelines and successfully enroll patients in a timely manner.

2. Question: How do you stay updated on regulatory changes and assess their impact on clinical studies? Can you provide an example of how this knowledge benefited a previous project? Answer: As a Site Activation Manager, I actively monitor and review the regulatory landscape to stay abreast of any changes that could affect our clinical studies. This involves collecting, analyzing, and disseminating accurate regulatory intelligence to support our projects. For instance, in a previous study, there was a significant update in the submission requirements of a regulatory authority in one of the countries involved. Thanks to my team’s proactive monitoring, we identified this change early and adapted our regulatory strategy accordingly. This timely adjustment enabled us to avoid delays in approvals, ensuring the project stayed on track.

3. Question: How do you approach building and maintaining relationships with key stakeholders, both internal and external, to support successful project delivery? Answer: Building strong relationships with key stakeholders is essential for successful project delivery as a Site Activation Manager. I prioritize effective communication and collaboration with all parties involved, including regions, countries, sponsors, and internal teams. By actively listening to their needs, addressing their concerns, and providing regular updates on project progress, I foster an environment of trust and cooperation. These relationships help ensure that all parties are aligned with the project’s objectives and facilitate efficient problem-solving when challenges arise.

4. Question: Can you describe your experience in overseeing start-up and/or lifecycle maintenance of clinical projects on a global scale? Answer: Overseeing start-up and lifecycle maintenance of clinical projects on a global scale has been a significant part of my role as a Site Activation Manager. I have managed projects across multiple regions, coordinating with diverse teams and adapting to different regulatory environments. This experience has given me a comprehensive understanding of the complexities involved in global studies and has honed my ability to develop tailored strategies for each region while maintaining consistent quality and compliance across the board.

5. Question: How do you ensure that project-related documentation, tracking tools, and project plans are accurately completed and maintained throughout the trial period? Answer: Accuracy and organization are critical to successful project management. As a Site Activation Manager, I emphasize the importance of diligently completing and maintaining project-related documentation, tracking tools, and project plans. By implementing robust systems and processes, I ensure that all project-specific information is up-to-date and easily accessible to the relevant stakeholders. Regular reviews and audits help identify any gaps or discrepancies, which can then be promptly addressed. This attention to detail and adherence to quality standards contribute to the smooth execution of clinical trials and successful study outcomes.

Editor’s Note: IQVIA Hiring BSc Life Science for Site Activation Job. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.