Secretary to CEO

**Secretary to CEO (Clinical Research Organization)**

**1. Role Overview**

The Secretary to the CEO in a Clinical Research Organization (CRO) provides high-level administrative, organizational, data, and communication support to the Chief Executive Officer and also works in close coordination with the Project Manager. The role ensures the CEO’s and Project Manager’s time is effectively utilized through calendar blocking, milestone tracking, and issue anticipation. The position requires strong foresight in managing uncertainties, excellent communication with international clients, and strict adherence to data integrity and compliance standards.

**2. Key Responsibilities. Administrative & Office Management**

Manage and Organize the CEO’s and Project Manager’s calendar, ensuring proper prioritization of meetings and tasks.

Organize domestic and international travel arrangements (flights, accommodation, itineraries).

Prepare meeting agendas, presentations, and reports relevant to CRO projects.

Maintain digital and physical filing systems for regulatory, operational, and strategic documents.

**B. Communication & Coordination**

Act as the primary point of contact between the CEO, Project Manager, and internal/external stakeholders (including international sponsors and clients).

Coordinate with department heads (Clinical Operations, Regulatory Affairs, Quality Assurance, Finance, HR) for project updates.

Draft professional communications, announcements, and responses.

Maintain confidentiality of sensitive research data and strategic plans.

**C. Meeting & Documentation**

Arrange board meetings, ethics committee interactions, sponsor/client discussions, and project review meetings.

Take accurate minutes of meetings, circulate action points, and follow up on pending tasks.

Prepare CRO-specific documentation such as trial progress reports, regulatory submission updates, and compliance reports.

**D. Research, Data & Information Support**

Collect and compile CRO industry updates, competitor intelligence, and regulatory changes for leadership reference.

Assist in preparing strategic proposals for new clinical trials, collaborations, or partnerships.

Maintain archives of past projects, clinical trial protocols, and investigator site details.

Ensure data management and data integrity across documentation and reporting.

Support in milestone management, proactively foreseeing issues and handling uncertainties.

**E. Compliance & Regulatory Support**

Ensure compliance with ICH-GCP and Good Clinical Practice (GCP) documentation requirements.

Track submission timelines for ethics committees and regulatory authorities.

Coordinate with QA teams for audit preparations.

**3. Required Skills & Competencies**

**Educational Qualification**

Graduate / Postgraduate (preferably from a recognized Business School) in Life Sciences, Pharma, Business Administration, or B.Tech.

**Technical Skills**

Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

Familiarity with clinical trial terminology, ICH-GCP guidelines.

Knowledge of Document Management Systems (DMS) and eTMF (advantage).

Strong expertise in calendar blocking, data management, data integrity, and milestone tracking.

**Soft Skills**

Excellent verbal & written communication (with strong international client-handling skills).

High level of confidentiality and integrity.

Multitasking, prioritization, and uncertainty management abilities.

Strong interpersonal skills to liaise with global stakeholders, regulatory bodies, and sponsors.

**4. Reporting Structure**

Reports directly to Chief Executive Officer (CEO)

Functionally reports to Project Manager for project-related activities.

Works closely with:
Clinical Operations Manager

Quality Assurance Lead

Regulatory Affairs Manager

HR & Finance

**5. Key Performance Indicators (KPIs)**

Timely scheduling and execution of CEO’s and Project Manager’s commitments.

Zero missed deadlines for regulatory/sponsor communication.

Accuracy, confidentiality, and integrity in document/data handling.

Efficient calendar blocking and milestone coordination.

Positive feedback from CEO, Project Manager, and international clients.

**5. Agreement Clause**

Pay: ₹17,000.00 - ₹22,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person