4 Protocol Design Jobs

As a Senior Clinical Project Manager at KlinEra, you will be responsible for overseeing and managing clinical trials in Mumbai, ensuring adherence to high-quality protocols and Good Clinical Practices (GCP). Your role will involve managing clinical operations, monitoring project timelines, and ensuring the achievement of project goals and milestones. You will work closely with research teams, provide oversight on trial management, and ensure regulatory compliance throughout the process. To excel in this role, you should possess skills in trial management and clinical operations, along with project management and research capabilities. Experience in protocol design and implementation is crucial, and your leadership and organizational skills will be essential for success. Strong communication and interpersonal abilities are necessary for effective collaboration in a fast-paced and dynamic environment. The ideal candidate will have previous experience in clinical trial management and hold a Bachelor's degree in a related field. Advanced degrees or relevant certifications would be advantageous in enhancing your qualifications for this position at KlinEra.,

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.,

Position Overview: We are seeking a highly qualified and experienced Director Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology, and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: o Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. o Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. o Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: o Oversee the planning, initiation, execution, and close-out of clinical trials. o Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. o Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: o Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. o Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: o Collaborate with biostatisticians and data managers to analyze clinical data. o Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: o Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. o Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: o Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: o Minimum 5-10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. o Prior experience in oncology research is highly preferred. o Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: o Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. o Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. o Strong communication, leadership, and problem-solving skills. o Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards

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