Data Manager III
Posted 1 hour 37 minutes ago by Quotient Sciences Limited
Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
Our proprietary and disruptive platform - "Translational Pharmaceutics " - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.
Why join us:Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast.
The RoleWe are looking for a Data Manager III to join our team in Edinburgh and play a key role in ensuring the accuracy and consistency of clinical trial data. You will work closely with internal teams and sponsors to maintain high-quality clinical databases in compliance with study protocols, Data Management Plans, SOPs, and regulatory guidelines.
Data Sciences at Quotient Sciences comprises six departments (including Data Management) and over 100 staff and provides an expert service in the data management, analysis and reporting of early phase clinical studies.
Each clinical study is set-up according to the clinical protocol which details the study design, objectives, dosing information, data collection and reporting methods. Other project team members will perform tasks such as database set-up, collection of data, reporting, etc; working as part of a team your role will be to perform tasks such as:
Main tasks and responsibilities- Act as Lead Data Manager for assigned studies under supervision
- Represent Data Management at multi departmental meetings
- Develop and maintain Data Management Plans
- Review clinical database build documentation and perform user acceptance testing (UAT)
- Create and finalise of Edit Check Specifications
- Conduct testing of edit checks
- Generate and review data listings
- Manage queries and query resolution
- Perform reconciliation of data from external vendors
- Generate Data Management Reviews and provide feedback to relevant departments
- Use eTMF to maintain Data Management study documentation
- Train mentor and provide oversight of junior Data Management team members
- Life sciences degree is preferable but not essential
- Good organisational skills
- Ability to work to deadlines and the ability to multitask in a fast-paced environment whilst maintaining quality standards
- Effective oral and written communication skills and ability to communicate effectively with internal and sponsor teams
- High attention to detail
- Working knowledge of GCP and relevant regulatory guidance
- Logical thinking and problem-solving abilities
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and InclusionQuotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.