Manager, Start Up

27 Premier Research Singapore Pte. Ltd.; Singapore; Sur place; SGD 120 000 - 180 000; Plein temps

Résumé du poste

Premier Research Singapore Pte. Ltd. is seeking a Manager, Start Up to join our Clinical Monitoring, Site Management and SSU team in Singapore.

You will lead staffing, drive startup timelines and optimize processes across CRO, device and pharma projects to deliver high-quality results. Ideal candidates bring 5+ years in clinical research with people management experience, strong regulatory and ICH/GCP knowledge, and a proven ability to partner with cross-functional teams to ensure study startups

Qualifications

• Undergraduate degree in clinical, science, or health-related field or licensed healthcare professional (e.g. registered nurse) or equivalent work experience.
• Minimum 5 years of clinical research industry experience; 2+ years in people management; CRO, device and/or pharmaceutical experience preferred.
• Working knowledge of FDA, European Regulatory and EC procedures as applicable.
• Working knowledge of ICH / GCP regulations.
• Knowledge of national/local health systems and practices for the country/region of site startup activities.
• Knowledge of the principals of project management.
• Current working rights for Singapore.

Responsabilités

• Manages staffing and resources to ensure departmental utilization.
• Drives study startup teams to meet project timelines.
• Assists in determining efficiencies for study startup to improve and streamline processes without compromising quality.
• Mentors direct reports on HR items, training and performance management.
• Maintains spreadsheets with metrics and provides monthly updates to upper management as needed.
• Applies analytics to reports and feasibility in the Study Planning stage.
• Ensures staff stay current on SOPs and updates to industry regulations and guidelines.
• Establishes harmonized process for study startup, maintenance and close out.

Connaissances

People management

Clinical research

Project management

Regulatory knowledge

Formation

Undergraduate degree in clinical/science/health

Description du poste

Premier Research is looking for a Manager, Start Up to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What you'll be doing:

• Manages staffing and resources to ensure departmental utilization
• Drives study start up teams to meet project timelines
• Assists in determining efficiencies for study start up to continually improve and streamline current processes without compromising quality
• Performs all aspects of managing/mentoring direct reports for HR items, training and performance management
• Maintains spreadsheets regarding metrics and provides monthly updates to upper management or as needed
• Applies analytic skills to reports and feasibility in the Study Planning stage
• Ensures department staff is current on company SOPs as well as updates to industry regulations and guidelines
• Establishes harmonized process for study start up, maintenance and close out

What we're looking for:

• Undergraduate degree or its international equivalent in clinical, science, or a health-related field from and accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required
• Minimum of 5 years of clinical research industry required. 2+ years people management experience. CRO, Device and/or Pharmaceutical experience preferred
• Working knowledge of FDA, European Regulatory and EC procedures as applicable
• Working knowledge of ICH / GCP regulations
• Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start up activities will be carried out
• Knowledge of the principals of project management
• This position requires current working rights for Singapore.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.