Senior Clinical Data Manager

This is a fully remote position, open to applicants in California, +9 more locations.

📋 Description

• Lead, strategize, and implement all data management activities for designated projects.

• Ensure the integrity, validity, and reliability of data in accordance with standard procedures, sponsor guidelines, industry best practices, and regulatory requirements.

• Supervise data management activities from the initiation of the study to database lock.

• Create data management plans, design CRFs and database specifications, test edit checks, and perform data reviews.

• Coordinate the development and testing of databases with programmers.

• Define and validate edit checks, manage queries, and process/reconcile electronic data from CIMS, safety databases, laboratories, and IRT.

• Oversee and mentor a team of 1-7 Data Management staff members.

• Provide training, guidance, and performance evaluations while managing project resources within budget and timelines.

• Participate in and lead both internal and sponsor meetings.

• Collaborate with project managers and teams, monitor study progress, provide issue status reports, and escalate data-related concerns.

• Develop and deliver training for investigators, clinical sites, project teams, and sponsors.

• Maintain and securely store study documentation in trial master files.

• Contribute to continuous improvement initiatives, SOPs, policies, and cross-functional working groups.

• Serve as a Subject Matter Expert and support process enhancements, issue escalation, and excellence in data management.

• Ensure adherence to standard procedures, sponsor guidelines, industry best practices, and regulatory standards.

⛳️ Requirements

• A minimum of one to two years of post-secondary certification in a relevant field of study.

• 4-6 years of relevant work experience in Clinical Data Management with continuous training.

• Preference for a specialty in Life Sciences or Clinical Research.

• CCDM (Certified Clinical Data Manager) certification is preferred.

• Ability to establish personal pace and prioritize tasks with a high degree of autonomy.

• Strong interpersonal skills with patience and tact for managing regular interactions with team members, vendors, and clients.

• Resumes should be submitted in English.

🏝️ Benefits

• Education Reimbursement program for full-time employees.

• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility).

• One-time office setup allowance.

• Working while visiting program – up to 4 weeks per year.

• Flexible Summer Hours Program from May – September.

• Employee referral incentive.

• Alimentiv Trust beneficiary after one year of employment and permanent membership after 5 years of employment for full-time employees.

• Optional formal mentorship program (Alimentorship).

• Country/region annual social events in person.

• Leadership development programs for people leaders based on seniority.

• Social committee and other optional initiatives.

• Additional benefits may be available depending on the country of employment and local policies and eligibility.