Provides strategic leadership for all clinical operations across development programs. Oversees portfolio of clinical trials from Phase I through Phase IV. Manages clinical operations team and develops organizational capabilities. Leads oversight of CRO partnerships and clinical outsourcing activities. Develops clinical operations standards, processes, and quality systems. Ensures regulatory compliance and inspection readiness across all studies. Manages overall clinical program timelines, budgets, and resource allocation. Supports clinical development strategy with operational feasibility inputs. Leads risk management for clinical programs and implements mitigation strategies. Represents clinical operations at governance committees and regulatory meetings. Builds and maintains relationships with investigators and academic institutions. Mentors clinical operations team members and drives performance management. Stays current with ICH GCP, adaptive trials, DCT regulations, and eClinical tools.

Develops pharmaceutical formulations for oral solid dosage forms including tablets and capsules. Conducts preformulation studies including solubility, polymorphism, and compatibility. Designs and executes formulation optimization experiments using DoE approaches. Prepares lab-scale and pilot-scale batches for stability and clinical studies. Conducts in-vitro dissolution studies and analyses release profiles. Prepares development reports, formulation records, and batch manufacturing records. Supports technology transfer of formulations to manufacturing scale. Collaborates with QC for analytical method development during formulation work. Investigates formulation failures and proposes corrective strategies. Stays updated with literature on excipients, polymers, and novel drug delivery. Supports regulatory filing by providing formulation data for drug dossiers. Maintains laboratory safety and GLP compliance in all development activities. Stays current with ICH Q8, Q9, Q10 guidelines and Quality by Design principles.

Dispenses prescription and OTC medications to inpatients and outpatients. Reviews prescriptions for accuracy, interactions, and appropriateness. Counsels patients on proper drug use, dosage, and side effects. Manages pharmacy inventory, procurement, and expiry monitoring. Coordinates with clinical pharmacologists for drug therapy reviews. Maintains narcotic and controlled substance records per NDPS Act. Participates in hospital formulary management committee. Provides medication reconciliation during patient admissions and discharges. Manages chemotherapy drug preparation in oncology pharmacy. Ensures compliance with drug storage and cold chain requirements. Trains pharmacy assistants and pharmacy technicians on protocols. Participates in medication safety and adverse event reporting. Prepares pharmacy consumption and cost reports monthly.

Position: Clinical Data Manager An exciting career opportunity exists for a motivated Clinical Data Manager to advance their professional journey. This role provides exposure to strategic initiatives and direct collaboration with senior leadership. Role Responsibilities: Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Education and Experience Requirements: Experience collaborating within cross-functional teams and matrix organisational structures. Excellent verbal and written communication skills; fluency in English is essential. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Minimum 35 years of progressive professional experience in a comparable role. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This role offers exceptional career growth, a collaborative culture, and a compensation structure aligned to market benchmarks.

Position: Clinical Data Manager We are currently recruiting a results-oriented Clinical Data Manager to strengthen our high-performing team. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Principal Responsibilities: Provide clinical site training on data collection standards and regulatory requirements. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Develop SOPs, work instructions, and training materials for clinical operations teams. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Candidate Requirements: Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Critical and strategic thinking skills with the ability to translate insights into clear actions. Sound understanding of organisational dynamics and stakeholder management in complex environments. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Effective presentation skills with the ability to communicate complex ideas with clarity. 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.