Premier Research is looking for a Senior Manager, Clinical Data Sciences to join our Clinical Data Sciences 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.
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We are Built by You. Your ideas influence the way we work, and your voice matters here.
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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:
Position Summary: Primary responsibility is to ensure the successful operation of projects and management of assigned personnel within Clinical Data Sciences. Serves as a member of the project or program-wide team with the lead responsibility to ensure that all captured data follow the rules outlined by the protocol and departmental plans. Responsible for mentoring and directly supervising all direct reports along with other employees as well as participating in initiatives for improving quality, utilization, efficiency, and resourcing.
- Serves as primary Clinical Data Sciences contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members
- Coordinates all tasks within the Clinical Data Sciences process between different team members from database development to database lock
- Prepares departmental plans, data entry guidelines, data reports and other documents required for preparing and completing databases
- Supports database development activities and coordinates database amendments in collaboration with the database development team
- Provides leadership and advice to Data Coordinators (DCs) and trainees on data science procedures, SOPs, ICH-GCP
- Provides and/or co-ordinates training and mentoring of DCs and trainees
- Helps to assess DC performance and execute annual appraisals, monitors career development, and performs end-of-probationary-period reviews
- Participates in process improvement initiatives including SOP writing and revisions
- Represents Clinical Data Sciences cross functionally in corporate initiatives
What are we looking for:
- Bachelor’s Degree or above (preferably in a Life Science); post-graduate degree prefered
- 12-15 years mastery in data management experience, with at least 8 years of supervisory/management experience
- Experience working across clinical data management systems and in-depth knowledge of at least two, preferably Medidata Rave and Calyx EDC
- Familiar with all phases of a study, e.g., pre-award, study startup/database setup, maintenance, and lock
Why choose 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 Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, 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.
