Job
Description
As the Feasibility Lead in Clinical Trials, you will be responsible for managing and delivering comprehensive feasibility assessments for early-phase clinical trials. Your role will involve ensuring the scientific, operational, and regulatory viability of proposed sites and countries, as well as supporting proposal development through collaboration with internal stakeholders and external clients. You will lead feasibility planning and execution to support project bids and early engagement efforts. Additionally, you will drive data-driven site and country selection strategies and serve as the subject matter expert in feasibility best practices to ensure alignment with global regulatory requirements. In terms of subject matter leadership, you will provide strategic input on protocol design, country, and site selection, stay updated on global feasibility trends and regulatory guidelines, and guide teams on interpreting feasibility data in line with business objectives. Moreover, you will contribute to process improvement initiatives and knowledge sharing activities within the organization. Your role will also involve project execution, where you will lead feasibility components across multiple projects to ensure timely and high-quality deliverables. You will be expected to anticipate challenges, design mitigation strategies proactively, and optimize internal resources to manage feasibility timelines effectively. Reporting and documentation will be a key aspect of your responsibilities. You will develop and present regular updates, dashboards, and ad hoc reports for both internal and external stakeholders. It is essential to maintain clear records for audits and client reviews to ensure transparency and compliance. Quality assurance is another crucial area where you will be involved. You must ensure compliance with ICH-GCP, company SOPs, and regulatory frameworks, participate in internal audits, and implement corrective actions as necessary. Promoting a culture of quality and continuous improvement will be integral to your role. Process optimization is also part of your responsibilities. You will contribute to the creation and refinement of SOPs related to feasibility, identify inefficiencies, and recommend enhancements to improve scalability and consistency within the organization. Team development and collaboration are essential components of this role. You will support the onboarding and mentoring of new or junior team members, foster a collaborative work environment, and facilitate cross-functional knowledge sharing. Additionally, participating in resource planning discussions to support strategic growth will be expected. Key Performance Indicators (KPIs) for this role include the timeliness and accuracy of feasibility reports, the success rate of project bids supported, client satisfaction in feasibility discussions, compliance with SOPs and regulatory requirements, contribution to team development and knowledge sharing, as well as clarity and transparency in feasibility reporting. Internal and external collaboration are critical aspects of this role. You will collaborate with department and functional heads internally (e.g., BD, Clinical Operations, Regulatory) and externally with sponsors, clients, and Global Site Networks. Candidate Requirements: - Education: Bachelor's degree in Pharmacy (mandatory); higher degrees in life sciences or clinical research are a plus. - Experience: Minimum 8 years of relevant experience in clinical trial feasibility or clinical development, with exposure to feasibility planning for early-phase clinical trials (Phase I/II) and global clinical trials preferred. - Technical Competencies: Strong understanding of clinical development and regulatory landscapes, proficiency in feasibility platforms, site databases, and data analytics tools, as well as CRM tools and Microsoft Office Suite (Excel, PowerPoint, Outlook). - Behavioural Competencies: Strong decision-making and problem-solving abilities, effective communication and interpersonal skills, coaching and mentoring mindset, ability to collaborate across functions and lead without direct authority.,
