CRA - Sr. CRA, FSP, Kuala Lumpur, Syneos Health Malaysia

Syneos Health, Inc.; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical solutions organization in Kuala Lumpur is seeking a Site Manager to oversee clinical site activities and ensure compliance with regulatory standards. You will perform site initiation, monitoring, and close-out visits, acting as a liaison with site personnel and managing investigational product inventory. The ideal candidate holds a Bachelor’s degree or RN in a relevant field, possesses excellent communication and interpersonal skills, and is prepared for frequent travel up to 75%. This role offers a chance to contribute significantly to clinical success in a global setting.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

• Perform site qualification, initiation, and monitoring activities.
• Manage investigational product inventory and compliance.
• Act as primary liaison with site personnel.

Skills

Excellent communication

Presentation skills

Interpersonal skills

Proficiency in computer skills

Education

Bachelor’s degree or RN in a related field

Job description

Updated: December 3, 2025
Location: Kuala Lumpur, Malaysia
Job ID: 25103888

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success through clinical, medical affairs and commercial insights to address modern market realities.

Why Syneos Health

• Passionate about developing people through career development, supportive line management, technical and therapeutic area training, peer recognition and total rewards.
• Committed to a Total Self culture that unites us globally and takes care of people.
• Building a company where diversity of thoughts, backgrounds, cultures and perspectives creates a sense of belonging.

Job Responsibilities

• Perform site qualification, initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice compliance. Evaluate overall site performance, communicate/escalate serious issues, develop action plans and maintain knowledge of applicable regulations and SOPs.
• Verify informed consent process, protect subject confidentiality and assess factors affecting safety and data integrity.
• Follow the Clinical Monitoring/Site Management Plan: assess site processes, conduct source document review, verify CRF data, resolve queries, support data capture and ensure electronic data capture compliance.
• Manage investigational product inventory, reconciliation, storage, security, dispensing and administration, including blinding, randomisation and labeling.
• Review Investigator Site File accuracy, reconcile with Trial Master File and ensure archiving per local regulations.
• Document activities via letters, trip reports, communication logs and other required project documents. Support recruitment, retention and awareness strategies and enter data into tracking systems.
• Understand project scope, budgets and timelines; manage site‑level activities and communications to meet objectives and deliverables.
• Act as primary liaison with site personnel and collaborate with the Central Monitoring Associate to ensure training and compliance of all site team members.
• Prepare for and attend investigator and sponsor meetings, participate in global clinical monitoring meetings, and attend required training.
• Provide audit readiness guidance at the site and project level, supporting audit preparation and follow‑up actions.
• Maintain working knowledge of ICH‑GCP guidelines and relevant regulations; complete required training. For Real World Late Phase, use the Site Management Associate II title and support the study lifecycle from site identification to close‑out.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Proficiency in computer skills and ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US‑only: compliance with privacy and access requirements for site deployment.

Equal Employment Opportunity

The Company is committed to compliance with the Americans with Disabilities Act, the EU Equality Directive and all relevant legislation, providing reasonable accommodations where appropriate.