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.
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.
We’re looking for a Manager Clinical Data Sciences (Data Management) join our Clinical Data Sciences team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
- 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 data science process between different team members from database development to database lock
- Prepares data science plans, data entry guidelines, data science 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 Clinical 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
- Onboards, trains, and evaluates new employees to facilitate integration into the department and to reach target utilization in a timely manner
- Supports department management in resource planning and allocation; hiring and management of data management staff; and achievement of department financial goals
- Directly manages a team of Lead Data Scientists and other Clinical Data Sciences staff as assigned
- Supports business development activities by participating in project costing estimates, proposal reviews/change order management and proposal defenses
- Acts independently as a representative of Clinical Data Sciences in audits/inspections
- Participates in process improvement initiatives including SOP writing and revisions
- Represents Clinical Data Sciences cross functionally in corporate initiatives
- Engages in recruitment for the department
- Leads/participates in task force groups that impact on the team
- Provides oversight of data management project progress and financial status including resolution plans for unexpected challenges
What we are searching for:
- Bachelor’s degree or above (preferably in a Life Science); post-graduate degree preferred
- Previous years mastery in Data Management experience, with supervisory/management experience
- Experience working across Clinical Data Management Systems and in-depth knowledge of at least one, preferably Medidata Rave and DataLabs EDCFamiliar with all phases of a study, e.g., pre-award, study startup/database setup, maintenance, and lock
- Knowledge of data mining and the application of data standards
- Knowledge of statistical principles and analysis
- Strong presentation skills
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 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.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.