Director of Clinical Operations (global)

Be among the first applicants.

OPIS

Batu Pahat

Remote

MYR 120,000 - 180,000

Be among the first applicants.

5 days ago

Job description

As the Director of Clinical Operations, you’ll report to the Chief Operating Officer and lead a multidisciplinary team to ensure the successful delivery of client projects. You will play a critical role in overseeing the operational aspects of multinational trials, maintaining the highest quality standards, and fostering a client-centric culture.

This is a full home based role in one of the European countries where OPIS has its affiliate.

Key Responsibilities:

Manage all operational aspects of multinational trials, ensuring projects are delivered on time, within budget, and according to contractual and regulatory requirements.
Ensure strict adherence to ICH-GxP guidelines, SOPs, and international regulatory standards across all projects.
Provide daily guidance, mentorship, and performance evaluations to clinical operations staff while fostering a culture of excellence, proactivity, and innovation.
Act as the primary liaison between clients, internal teams, and leadership. Prepare and present high-quality materials, such as agendas, project updates, and slide decks for meetings, bid defenses, and capability presentations.
Develop standards, tools, and processes to improve project efficiency. Ensure optimal resource allocation and planning to meet project goals effectively.
Identify potential risks and implement corrective action plans to mitigate quality, budget, or scope-related issues.
Partner with internal and external stakeholders to ensure seamless communication, alignment on objectives, and project success.
Contribute to proposals, feasibility studies, and operational strategies during pre- and post-award phases. Lead efforts to foster a client-driven approach throughout the team.
Monitor KPIs, ensure timely updates to systems, and provide regular progress reports to the board and sponsors.

Requirements:

Hands on, pro-active attitude.
Recent experience working in a CRO company.
A degree with a minimum of 15 years in clinical operations.
In-depth knowledge of ICH-GCP standards and global trial management.
Proven leadership skills in managing global teams and projects.
Strong organizational, analytical, and budget management capabilities.
Business acumen and a commitment to quality.
Proficiency in English and advanced business applications (Word, Excel, PowerPoint).

What we offer:
We offer a competitive salary and benefits package as well as opportunity to be part of a company that values growth, innovation, and customer success.
Please read the information notice on the processing of personal data in the candidates’ information section of our company website.
Who we are:
OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.