Manager - Clinical Research

Description:

- The Manager - Clinical Research will lead and manage clinical research programs, ensuring that clinical trials are conducted efficiently, ethically, and in compliance with global regulatory standards. The role involves overseeing clinical study planning, execution, monitoring, and reporting while collaborating with cross-functional global teams to ensure high-quality clinical outcomes.

Responsibilities:

- Manage the planning, execution, and delivery of clinical trials across multiple therapeutic areas.

- Ensure compliance with international clinical research regulations including ICH-GCP and regulatory authority guidelines.

- Oversee clinical operations including site selection, monitoring activities, and study timelines.

- Coordinate with internal teams such as regulatory affairs, pharmacovigilance, data management, and medical affairs.

- Monitor study progress, identify risks, and implement mitigation strategies to ensure timely completion of trials.

- Manage relationships with clinical research organizations (CROs), investigators, and research

Required Skills:

- Strong knowledge of clinical trial processes and regulatory frameworks.

- Expertise in ICH-GCP (International Council for Harmonisation Good Clinical Practice) guidelines.

- Experience in clinical study design, monitoring, and project management.

- Knowledge of clinical data management and trial documentation systems.

- Ability to manage global stakeholders and cross-functional teams.

- Strong analytical, leadership, and communication skills.

Experience: 8-12 Years

Qualification:

- Bsc/Masters degree in Pharmacy,

- Additional certifications in Clinical Research or Project Management are preferred.