FSP Manager Clinical Operations

ThermoFisher Scientific; Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

Thermo Fisher Scientific in Kuala Lumpur is seeking a Manager Clinical Operations to lead and develop a team delivering high-quality clinical monitoring and project execution across trials globally.

You will oversee performance management, training, resourcing, and adherence to ICH/GCP, SOPs/WPDs, and regulatory requirements while collaborating with senior leadership on strategic planning and business development. Travel may be required.

Qualifications

• 5+ years of clinical operations experience.
• At least 1 year in leadership roles.
• Strong mentoring and supervisory skills.
• Excellent clinical trials monitoring, remote and on-site.
• Familiarity with ICH/GCP, SOPs/WPDs and regulatory guidelines.
• Good organizational, negotiation and communication skills.
• Willingness to travel as needed.
• Solid knowledge of medical/therapeutic areas.

Responsibilities

• Lead and mentor a clinical operations team.
• Conduct regular performance appraisals and career discussions.
• Induct onboarding for new employees.
• Ensure timeliness and accuracy of timesheets and expense reports.
• Support resource allocation per local process.
• Deliver training on WPDs and SOPs; identify training gaps.
• Ensure adherence to ethics and regulatory standards.
• Coordinate QA audits and audits with clients/internal teams.
• Review systems to evaluate metrics and project status.
• Contribute to process improvements and risk-based monitoring.
• Assist bids and procurement of new business as required.
• Collaborate with senior management on strategic planning.
• Lead initiatives to improve department performance.

Skills

Leadership

Clinical monitoring

SOPs/WPDs

Regulatory knowledge

Project management

Communication

Teamwork

Problem solving

Travel readiness

Medical terminology

Quality assurance

Tools

Activate

CTMS

Preclarus

Clarity

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as Manager Clinical Operations – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As a Manager Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.

What You’ll Do:

• Manages staff, providing coaching, mentorship and work direction.
• Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports.
• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Assures adherence to good ethical and regulatory standards.
• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
• Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk-based monitoring approach.
• May provide input into bids and contribute to the procurement of new business where required.
• Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.
• May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

Education and Experience Requirements:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Advanced mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills; Remote and on-site
• Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
• Demonstrated ability to evaluate medical research data
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Good knowledge of English language and grammar
• Demonstrated use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent teammate with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.