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Life Science Job at IQVIA – Site Activation Manager Role – Apply Now

Role : Site Activation Manager

Primary Location : Thane, Maharashtra, India

Type : Full time

Job ID : R1362307

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 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

APPLY HERE

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Here are some interview questions and sample answers for the role of Site Activation Manager at IQVIA:

1. Can you describe your experience in site activation and management within the clinical research field?

Sample Answer: I have over 5 years of experience in site activation and management, including 2 years in a lead role. During this time, I have successfully managed the execution of site activation activities for various clinical studies. This includes site identification and selection, ethics and regulatory processes, and site contracting. I have a strong track record of ensuring compliance with regulatory requirements, such as ICH-GCP, and delivering projects within agreed timelines.

2. How do you prioritize tasks and manage multiple regions or projects simultaneously?

Sample Answer: Prioritization is crucial in site activation management, especially when handling multiple regions or projects. I use a systematic approach by first assessing project timelines, regulatory requirements, and sponsor priorities. I then create a detailed project plan with clear milestones and deadlines. Regular communication with the team and stakeholders helps in monitoring progress and addressing any issues promptly to ensure successful site activation.

3. Can you provide an example of a challenging regulatory situation you encountered in your previous role and how you resolved it?

Sample Answer: In a previous role, we faced a situation where a site had unexpected regulatory delays due to changes in local regulations. To address this, I initiated proactive communication with the local regulatory authorities and collaborated closely with the site to streamline the approval process. By providing clear documentation and addressing their concerns promptly, we were able to resolve the regulatory challenges and keep the project on track.

4. How do you stay updated on the evolving regulatory landscape in the clinical research industry?

Sample Answer: I stay updated on the regulatory landscape through a combination of methods. I regularly monitor regulatory agencies’ websites, attend relevant conferences and seminars, and subscribe to industry newsletters and publications. Additionally, I network with regulatory experts and colleagues to exchange information and gather insights into regulatory changes that may impact our projects.

5. Can you provide an example of a situation where you had to mentor or coach a colleague to improve their performance?

Sample Answer: Certainly, in my previous role, I noticed that a colleague was struggling to manage project timelines effectively. I took the initiative to mentor them by providing guidance on time management techniques and sharing best practices I had developed over the years. I also offered continuous support and encouraged open communication. As a result, my colleague improved their performance and became more efficient in managing their responsibilities.

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