Clinical Study Support Specialist

1 week ago

Petaling Jaya, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full time

**Responsibilities**:

- Assist with the coordination and management of clinical studies from initiation to close-out, ensuring smooth execution at all stages.
- Collaborate with investigators, service providers, and clinical research associates for efficient document collection and submission processes.
- Ensure timely submission to the boards and authorities as required, maintaining compliance throughout the study's duration.
- Oversee the setup, maintenance, and tracking of essential documents in electronic systems, ensuring compliance with relevant guidelines and regulatory standards.
- Ensure proper preparation and timely upload of study documents to maintain inspection readiness. Contribute to the finalization of study files and support clinical study close-out tasks, including archiving document.
- Help prepare and manage clinical and regulatory documents to meet technical and submission standards. Support the creation of regulatory submissions according to required guidelines.
- Keep tracking systems updated with accurate study progress and materials. Assist in the preparation of study-related contracts, payments, and administrative tasks as needed.
- Handle logistics and help organize internal and external study meetings, like investigator or monitor meetings. Prepare and share materials, making sure all stakeholders are well-informed..
- Make sure all study activities follow company policies, local laws, and ethical standards, including safety, health, security, and regulatory requirements.

**Job Requirements**:

- At least a Bachelor’s Degree in Life Sciences, Biology, Chemistry, Biochemistry or any equivalent qualification.
- Minimum 1 to 2 years of working experience as the **clinical administrative** role in the medical or any related field.
- Proficiency in computer literacy skills, especially in Microsoft Office Suites.
- Excellent oral and written English communication skills.
- Ability in leadership, interpersonal, and time-management skills.
- Ability to work in a team, attention to details, and multitasks.

**Consultant: Wei Li**

**Tel : 03 - 7954 8440**

**Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd**

No. 18, 2nd Floor, Jalan 14/14,
46100 Petaling Jaya,
Selangor

Pay: RM5,000.00 - RM7,000.00 per month

**Benefits**:

- Health insurance

Supplemental Pay:

- Performance bonus

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