Manager, Start Up

Premier Research is looking for a **Manager Start Up** to join our** Start Up** 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.
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We are Built for You.** 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.
- ** We are Built by You.** Your ideas influence the way we work, and your voice matters here.
- ** We are Built with You.** As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech.** **Join us and build your future here.**

The Manager, Study Start Up is responsible for the direct line management of Site Start Up Staff and/or Site Start Up Associates, including training, resourcing, performance evaluation and career development. In addition, the Manager, Study Start Up has oversight of site initiation, oversight of site essential documents during the life cycle of a trial, and execution and completion of study deliverables according to contractual agreements.

**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
- Prepares forecasts for staff utilization over the life of the study
- Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks
- Completes performance evaluation for direct reports for annual appraisals
- Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to study start-up
- Recognizes strategic opportunities to improve department productivity
- Establishes harmonized process for study start up, maintenance and close out

**What we are searching 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 1+ years people management experience, preferable in APAC
- Analytic skill set to review metrics and feasibility numbers
- Working knowledge of Start UP specialist including CA/MoH and REC/IRBs proceduresWorking knowledge of ICH / GCP regulations CRO and Pharmaceutical experience preferred
- Strong knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Fluent verbal and written English
- Good verbal and written communication and negotiation skills
- Good organizational and time-management skills, able to prioritize work to meet deadlines
- Customer service focused in approach to work, both internally and externally

**Why **ch**oose** Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the 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.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

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