IQVIA Hiring BSc Graduates
Job Title: Study Start-Up Manager (IQVIA Biotech)
Location: Thane, Maharashtra, India
Job Description: Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Roles & Responsibilities:
• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral memberof the study management team. 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 plan. 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. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
Qualification & Skills:
• Bachelor’s Degree Life sciences or related field Req
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities
IQVIA Hiring BSc Graduates. Here are Some Possible Interview Questions and Answers:
1. Can you provide an overview of your experience in managing site activation, maintenance, and regulatory activities for clinical studies or multi-protocol programs?
Answer: “I have extensive experience in managing site activation, maintenance, and regulatory activities for clinical trials. In my previous role at [Previous Company], I successfully managed the start-up phase of several studies, ensuring that all sites were initiated on time and in compliance with regulatory requirements. I have a strong track record of overseeing the scope of work, budgets, and resources to ensure efficient study start-up processes.”
2. How do you approach pre-award activities for clinical trials?
Answer: “Pre-award activities are crucial for ensuring the success of clinical trials. My approach typically involves thoroughly assessing the feasibility of the study, evaluating site capabilities, and estimating the resources required. I collaborate closely with cross-functional teams to develop comprehensive study start-up plans and budgets. This proactive approach helps us identify potential challenges early on and address them effectively.”
3. Can you describe a situation where you faced a budgetary constraint while managing study start-up activities? How did you handle it?
Answer: “In a previous role, we encountered a budgetary constraint while managing the start-up of a complex multi-protocol program. To address this challenge, I initiated a thorough review of the budget and identified areas where we could optimize resource allocation without compromising quality or compliance. I also negotiated with vendors and sites to secure favorable terms. By implementing these cost-saving measures and maintaining open communication with stakeholders, we were able to successfully manage the budgetary constraint without compromising the study’s integrity.”
4. How do you ensure that all regulatory activities are conducted in compliance with relevant regulations and guidelines?
Answer: “I prioritize compliance with regulatory requirements throughout the study start-up process. This involves staying up-to-date with the latest regulations and guidelines, conducting regular training sessions for the study team and site personnel, and performing comprehensive quality checks. Additionally, I establish strong relationships with regulatory authorities and ethics committees to facilitate smooth approvals and minimize delays. Continuous monitoring and documentation of regulatory activities are also key components of ensuring compliance.”
5. Can you provide an example of a challenging situation you encountered while managing study start-up activities and how you resolved it?
Answer: “In one of my previous roles, we faced a delay in regulatory approvals due to unexpected changes in local regulations. To address this challenge, I immediately engaged with the regulatory authorities to gain a clear understanding of the new requirements. Simultaneously, I worked closely with the study team to adapt our submission documents accordingly. By maintaining open communication with all stakeholders, we were able to navigate through the changes efficiently, expedite the regulatory approval process, and ultimately meet our study timeline.”
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