Feasibility Lead Business Development

8 - 12 years

0 Lacs

Posted:5 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Feasibility Lead in Business Development, you will be responsible for driving country and site feasibility activities for early-phase clinical trials. Your role will involve analyzing feasibility data, collaborating with internal teams and external clients, and providing strategic recommendations to support study planning and proposal development. Your critical role will focus on aligning feasibility operations with scientific, operational, and regulatory goals across global regions. Key Responsibilities: - Act as the go-to expert for feasibility practices across therapeutic areas. - Provide strategic input on site and country selection during protocol development. - Stay updated on global feasibility trends and regulatory landscapes. - Lead feasibility components of assigned projects, ensuring timely and high-quality delivery. - Coordinate multiple feasibility requests, ensuring optimal resource utilization and stakeholder expectations. - Identify potential risks and develop mitigation strategies in advance. - Prepare feasibility reports, dashboards, and trackers for internal and external stakeholders. - Ensure accuracy and transparency in all shared data. - Support audits and compliance reviews by maintaining documentation in line with ICH-GCP and company SOPs. - Ensure feasibility activities adhere to global regulations, SOPs, and ethical standards. - Support internal quality audits and implement corrective actions as needed. - Participate in the development and improvement of SOPs, work instructions, and process flows related to feasibility. - Identify gaps and propose scalable solutions for improved operational efficiency. - Support onboarding and mentoring of junior team members. - Foster cross-functional collaboration and share knowledge across teams. - Contribute to resource planning and team capability development. Qualification Required: - Minimum 8 years of experience in clinical research with strong feasibility and early-phase trial exposure. - Bachelors degree in Pharmacy is mandatory. Additional Details: The position of Feasibility Lead in Business Development offers a challenging opportunity to drive feasibility activities for early-phase clinical trials. You will play a crucial role in aligning feasibility operations with global goals and collaborating with internal and external stakeholders to support study planning and proposal development. This role requires expertise in feasibility practices, project management, reporting, compliance, process optimization, team collaboration, and mentoring. Additionally, exposure to tools such as Citeline, Veeva Vault, CTMS, Alchemer, and Excel/Power BI is preferred. You will also interact with internal department heads and external stakeholders like sponsors, clients, and CROs. Career progression from Project Manager to Business Development Lead is outlined for your growth within the organization. Role Overview: As a Feasibility Lead in Business Development, you will be responsible for driving country and site feasibility activities for early-phase clinical trials. Your role will involve analyzing feasibility data, collaborating with internal teams and external clients, and providing strategic recommendations to support study planning and proposal development. Your critical role will focus on aligning feasibility operations with scientific, operational, and regulatory goals across global regions. Key Responsibilities: - Act as the go-to expert for feasibility practices across therapeutic areas. - Provide strategic input on site and country selection during protocol development. - Stay updated on global feasibility trends and regulatory landscapes. - Lead feasibility components of assigned projects, ensuring timely and high-quality delivery. - Coordinate multiple feasibility requests, ensuring optimal resource utilization and stakeholder expectations. - Identify potential risks and develop mitigation strategies in advance. - Prepare feasibility reports, dashboards, and trackers for internal and external stakeholders. - Ensure accuracy and transparency in all shared data. - Support audits and compliance reviews by maintaining documentation in line with ICH-GCP and company SOPs. - Ensure feasibility activities adhere to global regulations, SOPs, and ethical standards. - Support internal quality audits and implement corrective actions as needed. - Participate in the development and improvement of SOPs, work instructions, and process flows related to feasibility. - Identify gaps and propose scalable solutions for improved operational efficiency. - Support onboarding and mentoring of junior team members. - Foster cross-functional collaboration and share knowledge across teams. - Contribute to resource planning and team capability development. Qualification Required: - Minimum 8 years of experience in clinical research with strong feasibility and early-phase trial exposure. - Bachelors degree in Pharmacy is mandatory. Additional Detai

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