Irshad Haque Email & Phone Number

Orchestrated the impeccable execution of clinical programs, enforced meticulous compliance, fostered strategic partnerships, mitigated risks, and nurtured a positive work environment. Directed the entire spectrum of clinical operations, navigated scientific, technical, and clinical facets with an unyielding focus on predefined objectives, timelines, budgets, quality benchmarks, and resource optimization. As a clinical development and operations expert, provided invaluable guidance, leveraged extensive expertise to conduct rigorous risk assessments and implemented robust mitigation plans for investigational products across diverse therapeutic areas.

Ensured seamless execution of clinical trials by designing and deploying effective processes with a focus on speed, cost and quality. Collaborated with senior management to develop risk mitigation plans for smooth implementation of clinical studies. Established and maintained relationship with key opinion leaders, investigator sites as well as consultants in different therapeutic indications for efficient execution of clinical studies. Independently led clinical program from conception to completion and ensure compliance as per ICH‑GCP guidelines, study protocol, SOPs, and other global regulatory standards. Swiftly resolved quality, timelines, and budget-related issues for an efficient workflow. Selected, monitored, and managed strategic partnership with external service providers (ESP), including CROs and other vendors as necessary to ensure execution of study as per agreed project plan. Provided strategic clinical input on protocol development, regulatory issues, and patient enrollment to clinical studies. Identified and mitigated potential risks associated with the study and program. Selected investigators as well as developed, reviewed, and finalized documents (Protocol, ICF, study manuals, eCRFs, IVRS, CSRs etc.) and plans for clinical study monitoring, safety management, data management, and statistical analysis. Ensured eTMF is accurate and up to date for audit/inspection readiness. Retained exceptional work quality by overseeing all clinical operations. Cultivated productive working relations with the health authorities for positive outcomes of inspections. Promoted a positive work environment to make them motivated. Key Accomplishments:• Implemented and successfully digitized complex hybrid/ DCTs with devices integration, direct to patient (DTP) and home healthcare professionals (HHCP) services.• Implemented RACI and PM Tracking tools for successful collaboration and business delivery solutions.

Brookhaven, New York

A seasoned leader in clinical operations with a track record of success across various therapeutic areas. Spearheaded program implementation, ensured study plan execution, and provided critical oversight of CRO partnerships. Instrumental in identifying and mitigating risks, optimizing talent resources, and fostering a motivating work environment.Key Achievements:• Managed and executed multiple highly successful clinical programs spanning North America, Latin America, and the Asia Pacific regions, resulting in a cumulative revenue generation exceeding $300 million. These efforts culminated in securing first-to-file marketing authorization for three pivotal products.• Expertly selected third-party service providers for efficient program execution in data management, bio-statistics, and medical monitoring.• Strengthened partnerships with CROs, study sites, and Key Opinion Leaders (KOLs), fostering collaboration and shared success.• Facilitated seamless integration with strategic partners and centralized vendors for CRO services, laboratory operations, imaging solutions, Interactive Voice Response (IVR)/Interactive Web Response System (IWRS), and study medication supply.Leadership, strategic acumen, and operational excellence consistently drove exceptional outcomes in the complex realm of clinical operations and program management.

Ahmedabad

Provided leadership for multiple clinical trials, overseeing critical aspects such as scope, timelines, quality, risk management, and budgets. Commitment to excellence was demonstrated through rigorous adherence to company policies and applicable regulations, ensuring the seamless management of clinical operations.Consistently drove operational efficiency and elevated project outcomes by collaborating closely with senior management and cross-functional leaders. Dedication to continuous improvement was evident in the successful implementation of substantial process enhancement initiatives, which significantly bolstered the overall quality of work.Managed essential operations, including schedule creation, work assignment, and the guidance and mentorship of our talented professionals. Holistic approach to leadership and management ensured the successful execution of clinical trials and the achievement of organizational objectives.Accomplishments:⇨ Applied leadership acumen to optimize clinical resourcing by continually evaluating and planning for resource allocation, ensuring efficient and strategic utilization.⇨ Spearheaded the implementation of cutting-edge systems and processes for the successful execution of clinical programs across a diverse range of therapeutic areas.⇨ Earned commendation for the seamless execution of the company's inaugural program using internal resources, achieving regulatory compliance across 20 investigator sites without any 483 observations.⇨ Demonstrated a knack for innovation and technology adoption by consistently delivering viable solutions for multiple projects, enhancing efficiency, and driving successful outcomes.

Mumbai

Played pivotal role in overseeing multiple projects with primary focus revolved around ensuring exceptional quality, on-time delivery, and unwavering client satisfaction. Provided steadfast leadership and invaluable guidance in the efficient management of clinical operations across diverse regions, including India, South Korea, Malaysia, the Philippines, Thailand, and Mexico.Played a significant role in shaping the proposal development process, ensuring that all client requirements were met to achieve margin targets. Actively participated in formal staff review procedures, encompassing performance evaluations and salary reviews.Recognizing the importance of performance metrics, established key performance indicators (KPIs) for all team members within the clinical operations department, fostering a culture of accountability and continuous improvement. Resolved critical issues and improved deficiencies promptly, leading to a 20% reduction in project timelines and ensuring flawless execution of clinical operations.Key ccomplishments:⇨ Pioneered clinical operations by establishing new teams and creating Standard Operating Procedures (SOPs) from the ground up in various regions, with a strategic vision of expanding the business globally.⇨ Garnered recognition for orchestrating two extensive global studies in previously uncharted territories, earning high praise from the investigator community.⇨ Spearheaded multi-center global clinical trials while nurturing enduring client relationships, fostering opportunities for repeat business.⇨ Devised and executed robust strategies that significantly enhanced profitability within the designated portfolio.⇨ Led the successful implementation of the CTMS - Oracle system across the organization, streamlining operations and optimizing efficiency

Mumbai

Assumed leadership roles in regional projects encompassing multiple phase-II and Phase III clinical studies. Responsibilities extended to the meticulous selection of resources to ensure the effective management of global clinical trials.Garnered recognition for adeptness in building a highly skilled clinical operations team, instrumental in overseeing the seamless execution of global clinical studies. Collaborated closely with sponsors, vendors, and cross-functional teams to identify and mitigate potential risks, ensuring smooth clinical delivery and project success.Actively participated in sponsor, investigator, and bid defense meetings, provided invaluable insights. Committed to excellence in consistently meeting enrollment while adeptly managing project risks, all while providing well-founded recommendations for mitigation strategies when needed.Key Achievements:⇨ Collaborated extensively with the quality management team to maintain consistently excellent quality standards throughout the entire project life cycle.⇨ Provided crucial support to the country head, contributing to the successful acquisition of business opportunities within just three months of the organization's establishment in India.⇨ Strategically planned and executed outbound training initiatives to enhance skillsets and boost overall work efficiency among the team.

New Delhi

Managed multiple Phase II, III, and IV clinical studies spanning across Oncology, Endocrinology, Neurology, Infections, and Cardiovascular therapeutic areas.

Masters In Pharmaceutics, Pharmaceutical Sciences

Bachelor'S Of Pharmacy, Pharmaceutics, Pharmacology, Pharmaceutical Engineering, Pharmaceutical Chemistry Etc.