Altasciences is seeking a Senior Lead Data Manager to oversee all data management activities from study start-up through database lock and archiving, independently supporting clinical studies and programs. This role acts as a departmental leader through mentoring and driving process improvements.
What You'll Do
- Follow and provide feedback on department and company SOPs, forms, templates, and policies.
- Act as the primary Data Management contact for the client and project team, proactively managing expectations.
- Develop strong client relationships driven by consistent study delivery in quality and timeliness.
- Develop, review, and maintain all study Data Management documentation.
- Coordinate with Database Developers to ensure effective database build and timely go-live.
- Ensure the clinical database adheres to CDASH guidelines for optimal SDTM dataset programming.
- Define eCRF and edit check specifications to support data collection and analysis per protocol.
- Guide effective QC review and UAT of the clinical database prior to release into production.
- Delegate and collaborate on data cleaning activities including listing review, query management, and vendor data reconciliation per ICH GCP guidelines.
- Ensure data are properly reviewed and cleaned per the Data Management Plan and sponsor guidelines.
- Track eCRFs, monitor key study metrics, and provide status reports to the sponsor and project team.
- Maintain Data Management documentation for the trial master file (TMF).
- Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
- Provide input into improving the efficiency of data management tasks.
- Lead and participate in intra and interdepartmental process and quality improvement initiatives.
- Oversee direct reports as assigned.
- Mentor and train other team members and/or develop training materials.
What We're Looking For
- A Bachelor's Degree in programming, health-related sciences, or a relevant field and 5-8 years of Data Management experience (experience may be considered in lieu of education).
- 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.
- Ability to prioritize workload.
- Superior attention to detail.
- Understanding of clinical research and the relationship of Data Management in the clinical study process.
- Proven history of continuous improvement.
- Strong technical aptitude and ability to adapt to multiple data management platforms.
- Strong knowledge of electronic data capture (EDC) clinical data management systems.
- Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to adapt to various IT systems.
- Fluency in English is an essential requirement.
Technical Stack
- Electronic Data Capture (EDC) clinical data management systems
- Microsoft Word, Excel, PowerPoint
Team & Environment
You will act as a leader and mentor within the Data Management department.
Benefits & Compensation
- Compensation range: $65,660 - $87,548
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
Altasciences is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
