Manager – Start Up

🔥 0 minutes ago

🌐 Australia, Singapore, +2 more countries – Remote

🇦🇺 Australia – Remote 🇸🇬 Singapore – Remote 🇹🇼 Taiwan – Remote 🇰🇷 South Korea – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 Venture Round on 2016-10

Healthcare • Consulting • Biotechnology

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Manage staffing and resources to ensure departmental utilization • Drive study start-up teams to meet project timelines • Improve and streamline study start-up and essential document maintenance processes without compromising quality • Support corporate initiatives and departmental advancement • Manage, mentor, motivate, and evaluate direct reports, including HR items, training, performance management, and career pathing • Maintain metric spreadsheets and provide monthly updates to upper management • Apply analytical skills to reports and feasibility during study planning • Maintain working knowledge of costing for study start-up tasks and staff sourcing • Recommend cost-reduction measures when appropriate • Contribute to business development, including evaluating and defining proposal specifications • Present to clients as needed • Use technology and search capabilities for study planning • Ensure staff awareness of company SOPs, industry regulations, and guidelines • Meet regularly with staff to ensure studies remain on target • Work in a global environment and coordinate multiple countries • Manage resourcing and staffing for newly awarded studies to ensure adequate staffing and timelines • Prepare staff-utilization forecasts over the life of studies • Ensure transition planning and stakeholder communication for staff changes • Provide time-entry guidelines and applicable training • Identify out-of-scope clinical-team tasks and ensure pre-approval • Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to study start-up • Participate in corporate initiatives and actions supporting company success • Share knowledge with other Managers and identify productivity opportunities • Develop training and implementation for own staff and other departments • Produce concise internal and external documentation and presentations • Establish harmonized processes for study start-up, maintenance, and closeout

🎯 Requirements

• Undergraduate degree or its international equivalent in clinical, science, or a health-related field from an accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required • Minimum of 5 years of clinical research industry experience • 2+ years of people management experience • Analytic skill set to review metrics and feasibility numbers • CRO, Device and/or Pharmaceutical experience preferred • Working knowledge of FDA, European Regulatory and EC procedures as applicable • Ability to handle multiple tasks to meet deadlines in a dynamic and changing environment • Working knowledge of ICH / GCP regulations • Strong knowledge of web-based communication tools for conferences and other IT systems required for the job • Knowledge of national/local health systems and cultural/professional practices appropriate to the country/region where site start-up activities will be carried out • Knowledge of the principles of project management • Fluent verbal and written English

🏖️ Benefits

• Flexibility and balance to support your life requirements • Skills and opportunities for professional growth and development