- Salary
- $86k – $1430k/yr
- Location
- San Diego, California · Atlanta, Georgia · Austin, Texas · Baltimore, Maryland · Boston, Massachusetts · Buffalo, New York · Chicago, Illinois · Cincinatti, Ohio · Columbus, Ohio · Dallas, Texas · Denver, Colorado · Detroit, Michigan · Houston, Texas · Jacksonville, Florida · Las Vegas, Nevada
- Workplace
- Remote
- Type
- Full-time
- Department
- Clinical Services
- Seniority
- Manager
- Source
- Lever
Description
Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.
If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!
Job Overview
Responsible for leading, planning and execution of all data management activities for assigned projects, ensuring focus on data integrity, validity, reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. Act as coach, mentor and/or Subject Matter Expert within the department, aiding Manager in process improvements, issue escalation and training development and delivery. Support the department and company in achieving objectives and strategic goals.
Key Responsibilities
- Lead Data Management Operations Serve as primary contact overseeing all data management activities from study start-up through database lock, including data management plan creation, CRF development, database specifications, edit check testing, and data review processes.
- Database Development & Quality Control Coordinate database build and testing with programmers, define and validate edit checks, perform data review and query management, and process/reconcile electronic data from multiple sources (CIMS, Safety database, labs, IRT).
- Team Leadership & Supervision Coordinate and supervise 1-7 Data Management staff members, providing training, mentorship, and conducting performance reviews while managing project resources within budget and timelines.
- Stakeholder Communication & Project Coordination Participate in and lead internal/sponsor meetings, work directly with project managers and teams, track study progress, issue status reports, and serve as escalation point for data-related issues.
- Training & Documentation Management Develop and deliver training programs for investigators, clinical sites, project teams and sponsors on data collection processes and tools; ensure study documentation is maintained and properly stored in trial master files.
- Department Development & Process Improvement Contribute to continuous improvement through information sharing, coach and mentor peers, participate in or lead development of SOPs/policies, and support cross-functional working groups.
- Strategic Support & Advocacy Act as Subject Matter Expert within the department, support manager with process improvements and issue escalation, and promote data management excellence internally and externally.
- Compliance & Standards Ensure all activities adhere to standard processes, sponsor guidelines, industry best practices, and regulatory standards while supporting departmental and company strategic goals.
Skills & Qualifications
- A minimum of a one-to-two-year post-secondary certification in a relevant field of study, and 4-6 years of related work experience in Clinical Data Management with ongoing training.
- Life Sciences or Clinical Research specialty and CCDM (Certified Clinical Data Manager) certification preferred.
- Ability to set personal pace and prioritize tasks with significant autonomy.
- Strong interpersonal skills with patience and tact for managing regular contacts with team members, vendors, and clients
Skills
Compliance
Benefits
Education Reimbursement program for full-time employeesMonthly Cell Phone and Remote Work Allowance (dependent on role eligibility)One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)Working while visiting program – up to 4 weeks per year!Flexible Summer Hours Program from May – SeptemberEmployee referral incentive – we know great people know other great people, and we think that warrants recognition!Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employmentOptional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!