Manager, Start Up

Premier Research Group; Singapore; Vor Ort; SGD 120.000 - 170.000; Vollzeit

Zusammenfassung

Premier Research Group is seeking a Manager, Start Up to join the Clinical Monitoring, Site Management and SSU team in Singapore. You will drive study start-up activities and lead staffing and resources to ensure timely delivery, while mentoring staff and maintaining compliance with SOPs and regulations.

The role requires strong project management, regulatory knowledge, and experience in CRO/pharma environments, with a focus on delivering high-quality start-up processes for life-changing

Qualifikationen

• Undergrad degree in clinical/health-related field or equivalent.
• Licensed health-care professional (e.g. RN) or equivalent experience.
• Minimum 5 years in clinical research.
• At least 2 years of people management experience.
• Experience with CRO, device and/or pharmaceutical settings preferred.
• Familiarity with FDA/EC regulations and ICH/GCP guidelines.
• Knowledge of local health systems and cultural practices.

Aufgaben

• Manages staffing and resources to maximize department utilization.
• Drives study start-up teams to meet timelines.
• Identifies efficiencies to streamline start-up processes without compromising quality.
• Mentors direct reports on HR, training and performance.
• Maintains metrics and provides monthly updates to management.
• Applies analytic skills to feasibility studies in planning stage.
• Ensures staff stay current with SOPs and regulatory guidelines.
• Establishes harmonized processes for start-up, maintenance and close-out.

Kenntnisse

People management

Project management

Regulatory knowledge

Analytical skills

Ausbildung

Undergraduate degree in clinical/health-related field

Licensed healthcare professional (e.g. RN)

Jobbeschreibung

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.