Data Manager II
Altasciences
Summary
The Data Manager II supports sponsors' research programs by contributing to the data cleaning efforts needed to provide clean, analyzable clinical data proficiently and independently.
Job description
About The Role
The Data Manager II supports sponsors' research programs by contributing to the data cleaning efforts needed to provide clean, analyzable clinical data proficiently and independently.
What You'll Do Here
- Perform data management cleaning activities including listing review, issuing, and closing queries, and external vendor data reconciliation per protocol, department and client standards, and ICH GCP guidelines.
- Ensure all fields are entered as appropriate and validation checks are complete.
- Appropriately track electronic case report forms (eCRFs) and queries, providing metrics as requested.
- Identify edit checks that fire incorrectly and missing data checks, range checks, and skip logic that are not in place or that do not function applicably.
- Support Lead Data Manager role.
- Understand the relationship between source and database forms about data entry, query creation, query resolution, and external vendor data reconciliation.
- Provide electronic data capture (EDC) system training (via WebEx) for clinical research associates (CRAs) and sponsor representatives.
- Lead and/or participate in user acceptance testing (UAT) for clinical databases according to SOPs, department processes, and established standards.
- Provide input into improving the efficiency of data management tasks.
- Participate in intradepartmental or interdepartmental processes and quality improvement initiatives.
- Provide mentoring and training to other Data Management team members.
What You'll Need to Succeed
- Bachelor's Degree in programming, health-related sciences, or relevant field. Relevant experience in lieu of a degree is acceptable.
- Excellent verbal and written communication skills.
- Professional attitude and strong interpersonal skills.
- Ability to work well with a multi-disciplinary team of professionals.
- Client-focused approach to work.
- Flexible attitude with respect to work assignments and new learning.
- Understanding of clinical research and the relationship of Data Management in the clinical study process.
- Strong technical aptitude and ability to adapt to multiple data management platforms.
- Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to understand and adapt to various IT systems.
Requirements
- Bachelor's Degree in programming, health-related sciences, or relevant field; relevant experience in lieu of a degree is acceptable
- Excellent verbal and written communication skills
- Professional attitude and strong interpersonal skills
- Ability to work well with a multi-disciplinary team of professionals
- Client-focused approach to work
- Flexible attitude with respect to work assignments and new learning
- Understanding of clinical research and the relationship of Data Management in the clinical study process
- Strong technical aptitude and ability to adapt to multiple data management platforms
- Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to understand and adapt to various IT systems
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- RRSP Matching
- Paid Vacation
- Paid Holidays
- Paid Sick Leave
- Bereavement Leave
- Employee Assistance Program
- Telehealth Programs
- Training & Development
- Employee Referral Bonus
- Telework when applicable
Company overview
Altasciences is a forward-thinking, mid-size contract research organization (CRO) and contract development manufacturing organization (CDMO) that provides integrated, full-service solutions for early phase drug development. Founded in 1992 and owned by Novo Holdings A/S, the company offers pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies. Their comprehensive services include preclinical safety testing, clinical pharmacology and proof of concept studies, bioanalysis, formulation development, manufacturing and analytical services, program management, medical writing, biostatistics, and data management. With over 1,800 employees across eight facilities in the U.S. and Canada, Altasciences has established itself as a trusted partner for drug development from lead candidate selection through clinical proof of concept and beyond. The company's integrated CRO/CDMO model enables seamless transitions between development phases, reducing complexities, mitigating risks, and accelerating timelines for clients ranging from startups to global pharmaceutical leaders.