Manages strategic relationships with major hospital systems and healthcare chains. Develops and executes hospital account strategies to achieve revenue targets. Coordinates inclusion of company products in hospital formularies. Conducts tender management and government hospital supply activities. Builds relationships with purchase committees, medical directors, and administrators. Organizes scientific presentations, clinical education, and product demonstrations. Monitors competitor activity within hospital accounts and develops counter-plans. Manages hospital tender documentation, pricing, and compliance requirements. Coordinates with supply chain for timely delivery of products to hospital accounts. Prepares account-wise sales analysis and growth plans for management review. Supports new product launches in hospital segment with targeted strategies. Manages outstanding payments and coordinates with finance for collections. Stays current with hospital procurement policies, NPPA pricing, and formulary trends.

Ensures manufacturing processes comply with GMP guidelines and SOPs. Reviews batch manufacturing records, analytical records, and deviation reports. Investigates Out of Specification (OOS) and Out of Trend (OOT) results. Prepares and reviews Corrective and Preventive Action (CAPA) reports. Conducts internal audits of manufacturing, QC, and support departments. Manages change control processes for manufacturing and quality systems. Reviews and approves product release documentation for finished goods. Coordinates with regulatory authorities during inspections and audits. Maintains quality management system documents and control procedures. Ensures environmental and personnel monitoring in cleanroom areas. Manages supplier qualification and vendor audit programs. Prepares annual product quality reviews (APQR) for all products. Stays updated with WHO-GMP, US-FDA, EU-GMP, and Schedule M guidelines.

Monitors clinical trial sites to ensure protocol and GCP compliance. Conducts site qualification, initiation, and monitoring visits. Reviews and verifies source data against case report forms. Identifies and resolves protocol deviations and data queries. Manages investigational product accountability at study sites. Assesses site performance and provides feedback to investigators. Prepares detailed monitoring visit reports for sponsor review. Ensures timely adverse event reporting from sites. Assists in site selection and feasibility assessments. Supports sites in regulatory submissions and IRB communications. Manages enrollment projections and site performance metrics. Provides GCP training to site personnel as needed. Stays current with FDA, EMA, and CDSCO regulatory requirements.

Position: Clinical Data Manager Our firm seeks a competent and professional Clinical Data Manager for a critical role in a high-performance environment. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Main Accountabilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Develop SOPs, work instructions, and training materials for clinical operations teams. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Essential Skills and Experience: Collaborative, proactive, and able to operate effectively with minimal supervision. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. 4+ years of experience with a demonstrated track record of growth and professional impact. Strong project management capabilities with experience in agile or structured methodologies. Superior writing and communication skills with experience preparing executive-level documents. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

Position: Clinical Data Manager An exceptional opportunity has arisen for a talented Clinical Data Manager to contribute to our mission. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Core Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Conduct structured literature reviews and contribute to scientific summaries and labelling. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Support collection and review of adverse event safety data from clinical and post-market sources. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Participate in regulatory inspections, health authority meetings, and internal audits. Minimum Qualifications: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Superior writing and communication skills with experience preparing executive-level documents. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.