Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

Premier Research is looking for a Senior Manager, Global Records Managements to join our Global Records Management 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 medical innovation that patients are desperate for.

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

What you will be doing :
ACCOUNTABILITY:

• The Manager/Sr. Manager is accountable for:Meeting all departmental budgeted deliverables for assigned studies and allocated line staff.
• Ensuring departmental utilization targets and performance metrics are met.
• Ensuring study performance metrics are met and scope of work is performed according to budgets and timelines.
• Ensuring that any out of scope activities are identified, itemized

The Manager/Sr. Manager responsibilities include:

• Initiating hiring requisitions; coordinating with HR/recruiting for candidate review; performing F2F and/or remote interviews; determining compensation with senior department management; selecting and completing hiring of assigned line and/or management staff globally
• Conducting on-boarding and providing position and system training of assigned line and/or management staff globally Identifying, reporting and resolving quality and efficiency concerns with records management work practices
• Managing assigned line and/or management staff globally as directed

What are we looking for:

• Minimum of an undergraduate degree, or its international equivalent, from an accredited institution majoring in records and information management, library science, clinical, science or health related field - or – an equivalent level of clinical trials records management experience.
• Essential document and/or TMF management experience in the CRO, pharmaceutical or medical device industry: 8+ years is required .
• eTMF migration experience is required
• Advanced knowledge in industry trends related to essential document and TMF management
• 5+ years line management experience providing coaching, guidance and feedback to junior management and/or staff
• 3 + years demonstrated departmental leadership skills Advanced knowledge of ICH-GCP guidelines and global regulations as they pertain to essential document and TMF management
• Excellent interpersonal skills with the ability to communicate effectively.
• Demonstrated flexibility and adaptability to changing requirements
• Ability to positively influence department performance and fostering Executive Leadership confidence regarding matters of significance
• Ability to multitask and work effectively in a fast-paced CRO environment

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.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.