(South) Senior Clinical Trial Operations Manager (Must Have Pharma/ Clinical Trial/ Biotech/ GM[...]

Recruit Express Pte Ltd.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading clinical trial organization in Singapore is seeking a Senior Clinical Trial Operations Manager to lead a team responsible for producing clinical trial supplies. The ideal candidate should possess strong leadership skills, GMP experience, and a background in pharmaceutical or biotech sectors. This role demands oversight of a team and ensuring compliance with regulatory standards. Competitive compensation and benefits offered.

Qualifications

• Must have a degree and experience from a pharmaceutical or biotech organization.
• Strong leadership skills necessary to oversee a team of 10.
• Experience in GMP and clinical trial-related operations is essential.

Responsibilities

• Head a team responsible for producing clinical trial supplies.
• Manage resource allocation and planning using S&OP data.
• Ensure compliance with regulatory standards and safety practices.
• Track and report KPIs to senior management.

Skills

Leadership skills

GMP experience

Clinical trial operations

Education

Min Degree

Tools

Clinicopia

JDE

SupplyFlex

Job description

(South) Senior Clinical Trial Operations Manager (Must Have Pharma/ Clinical Trial/ Biotech/ GMP Exp!) #HJC

Singapore

Working Hours

• 8am - 5pm / 9am - 6pm
• Fully on Site

Summary

• The Senior Manager, Operations will head a team responsible for producing clinical trial supplies.
• This includes pre-production and planning, label production, and manufacturing and packaging teams.
• This role will provide leadership and direction to deliver on business strategy, meet client requirements, achieve regulatory standards, ensure on-time delivery, quality, and efficiency targets, and establish safe working practices within a GMP environment.
• The position holder will be a key member of the Site Leadership Team.

Specific Duties, Activities and Responsibilities

• Leadership and Management: Provide direct leadership to a team involved in the production of clinical trial supplies, including pre-production/planning, label production, and secondary packaging.
• Resource Allocation: Using S&OP data and production plans, manage resource allocation, planning and risk mitigation to ensure the team is appropriately staffed to meet workloads.
• Risk Mitigation: Work with internal stakeholders to resolve workflow or technical issues that could disrupt operational demands.
• Technical Review: Responsible for the timely technical review of batch records to meet production timelines.
• Stakeholder Partnership: Maintain close partnerships with all stakeholder groups (e.g., PM, QA, Supply Chain) to ensure site delivery goals are achieved.
• Operational Performance Management: Manage Key Performance Indicators (KPIs) for operational areas, participate in the target-setting process, and prepare, maintain, and present monthly KPIs.
• Continuous Improvement: Develop continuous improvement (CI) strategies to advance operations, including implementing processes that minimize production costs and waste while maximizing production output.
• Regulatory Compliance: Ensure operational areas under your responsibility within the facility are in an 'audit-ready' state and that facility EHS regulations are adhered to for accident/loss prevention.
• Standard Practices: Develop or revise standard operational and working practices for operational areas.
• Audit Support: Represent operations and support QA with regulatory audits and client audits/visits, including providing audit responses and CAPAs related to operational processes.
• Quality Incident Management: Support the team with the investigation of quality incidents, including the implementation of CAPAs to minimise the chance of recurrence.
• Metrics and Reporting: Tracking and reporting of metrics to senior management and operations personnel to identify and drive performance improvements.
• Financial and Non-Financial Objectives: Support the Site Head with business line financial and non‑financial objectives, including the monthly M&P forecast, annual budget, and operating plans.
• System Knowledge: Basic working knowledge of department systems such as Clinicopia, JDE, SupplyFlex, and other platforms used by Operations.

Line Management Responsibilities

• Training and Compliance: Ensure team members are trained and following standard operating procedures.
• Staffing and Development: Conduct regular one‑on‑one meetings with direct reports to provide personalized support, guidance and development.
• Team Development: Hold routine operational team meetings to foster open communication and collaboration across the department.
• Goal Implementation: Implement department goals and objectives in line with top‑down company/division goals.
• Coaching and Mentoring: Provide ongoing coaching, mentoring, and development for direct reports, leading a highly motivated, efficient, and effective team.
• Employee Relations: Manage employee relations, including performance evaluations, new employee hiring, disciplinary notices, employee termination, rewards, and recognition according to company guidelines and performance requirements.
• Administrative Approvals: Manage team administration (e.g. review and approve team holiday requests and expenses).

Requirements

• Min Degree
• Must from pharmaceutical/ biotech/ clinical research organisation
• Strong leadership skills, need to oversee a team of 10 pax
• Strong in GMP experiences / clinical trial related operation work

For further information, please submit your resume to [e-mail]