Provides psychological assessments, diagnoses, and treatment for patients with mental health issues. Conducts therapy sessions, develops treatment plans, and uses various therapeutic techniques. Collaborates with other healthcare professionals to address.

Oversees the operational aspects of clinical programs and trials. Manages resources, staff, and logistics to ensure efficient and compliant execution of clinical activities. Develops and implements standard operating procedures, coordinates with various

Assists in analyzing clinical and research data, including statistical analysis and interpretation. Requires experience with data analysis tools and strong analytical skills

Assists in developing strategic plans for pharmaceutical products, including market analysis and competitive strategy. Requires strong analytical skills and understanding of strategic planning processes.

Assists in evaluating drug safety data, including risk assessment and adverse event reporting. Requires background in drug safety and experience with safety evaluation processes.

Monitor and manage clinical trials (Phase IIII; or post-approval studies), ensure protocol compliance.
CCRPS Clinical Research Training
On-site or remote monitoring (depending on trial), site visits, ensuring patient safety, data integrity, regulatory compliance (GCP, ICH guidelines).
CCRPS Clinical Research Training.
Coordination between sites, sponsors, investigators; documentation, reporting (adverse events, trial progress), liaising with CRO/project management.

For CRC / Trial Assistants: support administrative tasks, consent process, data collection, documentation, manage trial documentation, assist CRA.

Perform in-depth analysis of safety data (clinical trial SAEs, post-marketing ADRs), medical coding, support safety review, collaborate with medical reviewers/physicians often using databases like Argus.

Perform in-depth analysis of safety data (clinical trial SAEs, post-marketing ADRs), medical coding, support safety review, collaborate with medical reviewers/physicians often using databases like Argus.

Job Description (JD):

Define regulatory strategy across global regions for NCEs, generics, or biosimilars.

Liaise with global agencies (FDA, EMA, TGA, MHRA) for approvals.

Oversee preparation and review of global dossiers.

Provide regulatory intelligence and risk assessment inputs during product development.

Required Skills:
Global submission experience, in-depth regulatory knowledge, cross-functional leadership.

Manages the development and review of clinical study protocols. Ensures protocols are scientifically sound and comply with regulatory guidelines.

Coordinates with research teams to integrate feedback and updates.