Clinical Lead

4 weeks ago


Kuala Lumpur, Malaysia Novotech Asia Full time

This position is open to all APAC countries including AU and NZ.

**Brief Position Description**:
The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve project deliverables.

**Minimum Qualifications & Experience**:

- Graduate in a clinical or life-science related field.
- Must have working experience in managing clinical operations deliverables & leading the CRA team across multi-region in global/regional studies
- Need to demonstrate the working experiences in clinical study deliverables, study quality & system compliance management and creation of study plans, understanding of vendor management
- Must have the ability to meet deadlines in a fast and dynamic environment.
- Good communication skills and fluency in both verbal and written English

**Responsibilities**:

- Lead site identification and site selection activities.
- Prepare for and attend investigator meetings; may present materials.
- Review Monitoring Visit Reports (MVR) and follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS.
- Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies.
- Assist PM with response to audit findings and assist the clinical team with completion of any CAPA review and documentation.
- Work with PM to manage clinical resources to ensure monitoring activities are within budget and notify the PM of any changes required or changes in scope.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.



  • Kuala Lumpur, Kuala Lumpur, Malaysia HFG Insurance Recruitment Full time

    Job DescriptionThis is a high-visibility group-level role responsible for providing clinical leadership and oversight for Connected Care initiatives across markets.Connected Care emphasizes personalised, seamless care journeys to transform the care experience for clients' customers by ensuring access to the right care, in the right place, at the right time...


  • Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    Key ResponsibilitiesAs a Clinical Research Operations Lead at IQVIA, you will be responsible for directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Your key responsibilities will include overseeing the execution of site activation, developing and implementing...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a dynamic and global Contract Research Organization (CRO) committed to delivering high-quality clinical research services. Our company has grown organically from a handful of countries to a global presence, while maintaining our independence and freedom to operate.Job RequirementsWe are looking for a knowledgeable and team-oriented Senior Clinical...


  • Kuala Lumpur, Kuala Lumpur, Malaysia MediPulih Group Full time

    About MediPulih GroupWe are a leading provider of medical services in Kuala Lumpur, committed to delivering exceptional patient experiences.Key ResponsibilitiesLead and manage clinic operations within assigned regionsDrive performance improvements across multiple clinicsWork collaboratively with clinic teams to achieve business objectivesRequired Skills and...


  • Kuala Lumpur, Malaysia Medtronic Full time

    **Careers That Change Lives** As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced...


  • Kuala Lumpur, Kuala Lumpur, Malaysia MediPulih Group Full time

    About the RoleWe are seeking an experienced Area Manager to lead and manage clinic operations within our assigned regions.Key AccountabilitiesLead and manage clinic teams to achieve business objectivesDevelop and implement operational strategies to improve clinic performanceAnalyze data to identify areas for improvement and implement changes as...


  • Kuala Lumpur, Malaysia IFloss Dental Full time

    Clinic Operational Manager **Position**:Clinic Operational Manager **Reports To**:Clinic Director **Job Overview**: **Key Responsibilities**: **Operational Management**: - Oversee daily operations of all three clinic branches to ensure efficiency and effectiveness. - Coordinate with different departments to streamline processes and improve patient...


  • Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    Job SummaryWe are seeking a highly skilled Site Activation Manager to join our clinical Functional Service Provider (cFSP) team at IQVIA Argentina.Key Responsibilities:Site Activation and Maintenance: Direct and manage the delivery of site activation, maintenance, and regulatory activities for assigned projects in accordance with the agreed scope of work and...


  • Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job DescriptionWe're seeking an experienced Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia.About the Role:Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring visits.Be involved in study set-up, including site...


  • Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Join Our TeamWe are seeking a highly motivated Clinical Trials Manager to join our team at Syneos Health, Inc. In this role, you will be responsible for coordinating communications between study team stakeholders and global teams of site-facing site contract & budget negotiators.Your Key ResponsibilitiesClinical Study Agreements: Collaborate with global...

  • Clinical Specialist

    1 week ago


    Kuala Lumpur, Malaysia Medtronic Full time

    **Careers that Change Lives** Bold thinking. Bolder actions. We are Medtronic. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered...


  • Kuala Lumpur, Kuala Lumpur, Malaysia ICON Full time

    We are seeking an experienced Compliance Lead to join our Clinical Research Operations team. As a key member of our team, you will be responsible for ensuring the highest standards of clinical quality compliance across our global operations. This will involve working closely with local country operations management to develop and implement effective...


  • Kuala Lumpur, Malaysia Organon Full time

    **Malaysia Women’s Health Clinical Educator**: **Primary Function of Position**: Reporting to the Women’s Health Lead, the Clinical Educator will be responsible for education of current and potential clinicians, providing them with clinical education of medical devices. The Clinical Educator, WH will partner closely with Key Account Managers of...


  • Kuala Lumpur, Kuala Lumpur, Malaysia ICON Full time

    As a key member of our team, you will be responsible for ensuring the highest standards of clinical quality compliance in our organisation. This involves serving as a local expert on ICH-GCP and local regulations, conducting impact assessments to identify areas for improvement, and developing effective solutions to ensure compliance.You will work closely...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Contracts Specialist to join our team at Syneos Health, Inc. In this role, you will be responsible for establishing and maintaining training material for site contracts lead team and site contract negotiators.Your Key ResponsibilitiesNegotiate Clinical Study Agreements (CTAs): Collaborate with...


  • Kuala Lumpur, Malaysia BIOTRONIK Full time

    BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success...


  • Kuala Lumpur, Malaysia BIOTRONIK SE & Co. KG Full time

    BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success...


  • Kuala Lumpur, Kuala Lumpur, Malaysia ICON Full time

    Key Responsibilities:Ensure compliance with ICH-GCP and local regulations through ongoing training and awareness initiativesConduct regular audits to identify areas for improvement and develop corrective action plansCollaborate with local country operations management to develop and implement effective compliance strategiesProvide training to staff on...


  • Kuala Lumpur, Malaysia Zimmer Medical (Malaysia) Sdn Bhd Full time

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...