Clinical Research Specialist/ Associate/ Lead/ Manager

CRA, Clinical Research, SSU

Your new company

This global pharmaceutical leader, established in the late 19th century, has a strong presence in Malaysia through its local subsidiary based in Selangor. The company is known for its innovation-driven approach, focusing on developing first-in-class and best-in-class therapies through cutting-edge research, global collaborations, and advanced technology.

Your new role

  • Initiate site-related activities for clinical trials, including the collection and submission of regulatory documentation, customisation and negotiation of informed consent forms, and serving as the primary liaison with the site’s ethics review board (ERB) and competent authority (CA), where applicable.

  • Lead budget discussions with site personnel and internal stakeholders, secure fully executed contracts, monitor site compliance with required training, and drive timelines in alignment with organisational priorities.

  • Maintain active communication with sites to facilitate start-up, ongoing collaboration during trial maintenance, and smooth close-out processes.

  • Collaborate with Clinical Design, Delivery, and Analytics (CDDA) teams, as well as external parties or CROs, to ensure seamless coordination throughout site activation, maintenance, and closure.

  • Ensure all country-specific regulatory and data privacy requirements are accurately reflected in submission documents and relevant systems.

  • Identify, communicate, and resolve operational issues, escalating to management or quality teams when necessary.

  • Oversee the delivery and management of clinical trial materials to support site initiation.

  • Coordinate the translation of clinical trial documents and ensure the quality of translated materials.

  • Maintain accurate trial and site performance data on internal systems.

  • Organise and update Trial Master Files and reference libraries for future use.

  • Share feedback and lessons learned to support continuous improvement initiatives.

  • Proactively manage shifting priorities and timelines.

  • Adhere to procurement, legal, and financial procedures and requirements.

  • Ensure compliance with local regulations, company policies, and Good Clinical Practice (GCP) standards.

  • Clinical Trial Payment Responsibilities:

  • Manage the end-to-end purchase-to-pay process for investigator payments, including vendor setup and management, purchase order creation and updates, processing of visit payments and invoiceable items, budget tracking, and reconciliation of site payments during close-out.

  • Identify and resolve payment-related issues such as outstanding, duplicate, or rejected invoices, and communicate these effectively to relevant stakeholders.

What you'll need to succeed

  • Bachelor’s degree preferably in a scientific or health-related field

  • At least one (1) year for Associate, three (3) years for Senior Associate, and five (5) years for Lead. Previous clinical trial experience or relevant experience preferred. For Associates/Leads supporting clinical trial payment, P2P (Purchase to Pay) experience is preferred.

  • Understanding of the overall clinical development paradigm and the importance of efficient site activation.

  • Applied knowledge of project management processes and skills.

  • Appreciation of / experience in a compliance-driven environment.

  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract).

  • Effective communication, negotiation, and problem-solving skills.

  • Self-management and organisational skills.

  • Language Capabilities – English (read, write, conversation) and local language, as applicable.

What you'll get in return

  • Career progression

  • Competitive Package

  • Regional Exposure

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Malaysia
Specialism
Life Sciences
Ref:
1279712

Talk to a consultant

Talk to Mikhael Raffie, the specialist consultant managing this position, located in Sunway
Corporate Suite 19-01 at Sunway Resort Hotel,, Persiaran Lagoon,

Telephone: +60 3-7890 6337