Job Description

1. Clinical Research

a) Clinical Research Associate (CRA)

• Monitor clinical trials to ensure compliance with protocols and regulatory requirements.

• Manage trial documentation and ensure timely reporting of study progress.

• Conduct site visits, train site staff, and resolve operational issues.

• Collaborate with project managers, data managers, and regulatory teams.

b) Clinical Trial Manager

• Oversee the planning and execution of clinical trials.

• Manage budgets, timelines, and resources.

• Ensure trial milestones and regulatory submissions are met.

• Coordinate cross-functional teams (CRA, Data Management, Regulatory Affairs).

2. Regulatory Affairs

a) Regulatory Affairs Specialist

• Prepare and submit regulatory documents for clinical trials and product approvals.

• Ensure compliance with local, regional, and global regulations.

• Communicate with regulatory authorities and provide guidance to internal teams.

• Maintain regulatory documentation and track submission timelines.

b) Regulatory Project Manager

• Lead regulatory projects from planning to submission.

• Coordinate teams across clinical, medical, and quality departments.

• Provide strategic regulatory guidance to ensure timely approvals.

• Monitor project timelines and deliverables.

3. Biometrics & Data Science

a) Biostatistician

• Design statistical analyses for clinical studies.

• Generate tables, listings, and figures (TLFs) for reports.

• Interpret study data and provide statistical insights for decision-making.

• Collaborate with clinical and medical teams on study outcomes.

b) SAS Programmer / Data Analyst

• Manage, clean, and analyze clinical trial datasets.

• Prepare data for regulatory submission.

• Develop statistical programs and reports.

• Ensure data quality and compliance with Good Clinical Data Management Practices (GCDMP).

4. Project Management

a) Project Coordinator

• Support project managers in planning and tracking study progress.

• Coordinate meetings and manage study documentation.

• Track budgets, timelines, and milestones.

• Assist with cross-functional communication.

b) Project Manager

• Lead cross-functional teams in clinical studies.

• Ensure studies are delivered on time, within scope and budget.

• Manage resources, risks, and stakeholder expectations.

• Report project status to senior management and clients.

5. Medical and Scientific

a) Medical Writer

• Prepare clinical study protocols, reports, and regulatory documents.

• Ensure documents meet scientific, medical, and regulatory standards.

• Collaborate with clinical, regulatory, and biostatistics teams.

• Maintain consistency and accuracy across medical documentation.

b) Medical Monitor / Medical Director

• Provide medical oversight and expertise for clinical trials.

• Review safety data and advise on trial design and patient management.

• Ensure adherence to medical standards and ethical guidelines.

• Support regulatory submissions and investigator queries.

6. Laboratory Services

a) Laboratory Technician

• Conduct laboratory testing and sample analysis for clinical trials.

• Ensure compliance with SOPs, safety regulations, and quality standards.

• Record and maintain laboratory data accurately.

• Support biomarker testing, pharmacology studies, or safety labs.

7. Corporate Roles

a) HR Generalist / Recruiting Specialist

• Manage recruitment, onboarding, and employee relations.

• Administer HR policies and benefits.

• Support talent development programs and employee engagement initiatives.

b) Finance Analyst

• Prepare financial reports, budgets, and forecasts.

• Analyze financial data for business decisions.

• Ensure compliance with corporate policies and accounting standards.

Skills Required

• Communication Skills
• Leadership skills
• Problem Solving & Time Management