Job Description

Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of an esteemed, independent cancer research organization in Malaysia. In their continuous efforts to reverse cancer through research of new ways of prevention and cure, our respected client is seeking a Clinical Trials Manager to oversee the execution of a range of investigator-initiated clinical trials focused on cancer. This opportunity is based in Selangor, Malaysia.You will collaborate closely with the organization\'s research teams, who are engaged in developing therapeutic cancer vaccines, repurposing existing drugs for head and neck cancer treatment, and evaluating biomarkers for breast cancer. Additionally, you will liaise with both internal and external stakeholders, particularly the Clinical Working Groups for Breast Cancer and Head and Neck Cancers, to advance these clinical trials.Job Responsibilities:

• Responsible for implementation of the organization\'s strategy for the Clinical Research, focusing on investigator-initiated clinical trials.

Clinical Trials Portfolio:

• Ensure all clinical trials within the CTU portfolio meet milestones in budget, resources, and timelines.
• Acting as the key contact for site investigators and pharmaceutical industry.
• Developing protocols and informed consent forms, preparing and submitting regulatory applications.
• Reviewing Clinical Trial Agreements, and oversee the supply of study materials.
• Establishing a data management plan, designing eCRFs using REDCap, a risk management plan, solving problems and resolving conflicts.
• Developing contingency plans to mitigate clinical operational risks.
• Evaluate feasibility of potential investigator sites or Principal Investigators for new clinical trials.
• Work with PI team on Clinical Study Reports and assist research scientists with manuscript writing and submission.
• Support expansion of the CTU portfolio by developing clinical trial proposals, preparing budgets and timelines, and seeking funding.
• Draft grant applications for new trials and liaise with pharmaceutical companies on proposal submissions.
• Maintain a registry of Investigator Sponsored Programme (ISP) and RFP applications.

Compliance & Quality Management Planning:

• Support the study manager and research scientists with site management for internal trials, including reviewing IRB/EC documents and providing SIV training.
• Establish and oversee study monitoring plans for internal and external trials, and review reports from the CRA.
• Assist in developing QMS and maintaining SOPs for clinical trial operations.
• Ensure compliance with GCP guidelines, ethics, and regulatory requirements through periodic monitoring and training.
• Train personnel on the company\'s Clinical Operational SOPs.

Additional Responsibilities:

• Supervise the Clinical Research Associates
• Deputise for the Chief Scientific Officer or the Head of Clinical Trials Unit and to represent the company when needed.
• Prepare and present papers for the Management or Board of Trustees of the company.
• Be accountable for designated projects as necessary.
• Manage other administrative tasks as required

Requirements:

• Possess a Bachelor\'s Degree, with at least 5 years of working experience in clinical research or clinical trials.

• Strategic mindset, put information in context and interpret complex information
• Good at interacting confidently with all levels of stakeholders including donors, senior academics and researchers.
• Able to communicate persuasively either in one-to-one sessions with grant committees or with groups of lay individuals.
• Strong leadership, motivational and team-management skills.
• Good written and oral communication skills, with strong attention to detail.
• Proficient in Microsoft Office Application usage.
• Strong organisational skills, able to prioritise, juggle multiple tasks and meet deadlines.

Monroe Consulting