Senior Lead Data Manager

Premier Research is looking for a **Senior Lead Data Manager **to join our** Functional Services** 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 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.**

**What you'll be doing**:
Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan

Provide input to and review of Data Management Plans in support of clinical study deliverables

Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process

Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly

Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required

Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements

Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required

Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.

Mentor and train Data Managers

Performs additional duties as assigned

Ability to perform overnight business travel, up to 10%

**What we are searching for**:
Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience

3 to 5 years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).

Demonstrates excellent English verbal and written communication skills

Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)

Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership

Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

**Why choose Premier?**

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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