Senior Clinical Project Manager
SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company focusing on the development of novel immunotherapies for patients with pathogenic infections and its associated cancers. Our strategy is to harness patient's immune system by redirecting cellular responses toward pathogens and its associated cancer using adoptive cell therapy, bispecific antibodies and vaccines.
At SCG Cell Therapy Pte Ltd, you will have the chance to develop your career and be part of the global team. We believe that creating opportunities for our people and developing people skills is crucial to our growth and success. If you are inspired to change the lives of patients using cutting edge technology all over the world, we’d love to hear from you.
About the role
As a Clinical Project Manager (CPM), you will manage SCG’s ongoing and new global clinical trials (multi-centre, multi-national excluding China). You will oversee the implementation and monitoring of clinical trials to ensure that trials are conducted in accordance with ICH/GCP and applicable regulations, within time and budget, and with quality. The SCPM is responsible for the overall execution of the project.
In addition, you will also act as a Clinical Trial Manager (CTM) for APAC clinical trials and will maintain a full ownership of several countries studies in APAC and ensures effective and efficient delivery of the respective countries’ operational aspects in accordance with the study development plan and ICH/GCP standards, company SOPs, and local regulatory requirements.
Responsibilities
● Manage and oversee global clinical trials, including deliverables from all relevant internal stakeholders as well as vendors in accordance with timelines, quality, and GCP.
● Develop work breakdown structure (WBS) for relevant projects using a project management tool to identify scope, cost and deliverables and delegate tasks to the relevant stakeholders.
● The primary liaison of the clinical trial sites, and service providers.
● Identifies critical trials success factors through tracking, analysis, and reporting including probability, impact, and risk mitigation strategies.
● Develop budget and expense review strategy; creates proactive cost containment strategies and communicates with study team; regularly reviews budget/expenses with the study team.
● Review and refine clinical operational processes and take responsibility for identifying new approaches/systems to improve efficiency and delivery of work.
● Provides creative solutions to ensure on-time delivery whilst identifying problems, and proactively recommending solutions.
● As CTM, you will manage all end-to-end operational aspects of clinical trials, including but not limited to early viability, feasibility, allocation and site selection
What will you need to succeed?
● Previous experience in the clinical research industry (sponsor or CRO) is a must
● Bachelor’s degree; a PMP certification is desired
● 5-8 years of clinical operation experience
● Previous experience with standard project management process desired
● Knowledge of GCP and FDA regulatory requirements is required.
● Good understanding of the drug development process.
● Excellent written and verbal communication skills, as well as interpersonal skills.
● Familiar with at least one project management tool
● Exceptional time management and conflict resolution skills required.
● Ability to interact with all levels of management, study site personnel, and vendors
● Possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
