Manager, Clinical Data Management (Remote, US)

Position Summary

The Manager, Clinical Data Management executes operational objectives, policies, procedures and work plans for the development of clinical study databases. As an integral member of the Clinical Operations team, this position manages data management activities and interfaces with the rest of the Clinical Operations team to ensure that standards are communicated properly, timelines are met according to objectives and goals, data reporting needs are scheduled and addressed, and the quality of data management deliverables are monitored. Ability to interact collaboratively cross-functionally, in external partnerships and oversee CROs is a critical responsibility. Knowledge of Industry and regulatory standards with an ability to translate clinical team objectives into operational actions maximizing the current technical platforms will be a critical skill set.

**Position can be based remotely, within the US.**

Principal Responsibilities

• Responsible for management of the clinical database vendor (Veeva Vault) in collaboration with the Clinical Operations team.
• Maintain the operational objectives for the EDC system used by Clinical Operations and Global Scientific Affairs.
• Support the development of policy and procedures for data management activities supporting EU MDR data collection goals.
• Manages data activities for all clinical trials as well as the design, review, and validation of the clinical database to deliver data for analysis in compliance with standard operating procedures, and regulatory agency guidelines.
• Designs case report forms (CRFs) as well as data edit checks in collaboration with Clinical Operations.
• Responsible for the development of any clinical database (including by an EDC/CRO vendor) and will manage the user acceptance testing (UAT) of the clinical database.
• Manage vendors providing safety services while ensuring the accuracy of safety data and reports and maintaining compliance with associated committee charters.
• Contribute to the development and implementation of data management department policies, standards operating procedures. Recognize potential obstacles and partner with team members to resolve them within set timelines.
• Proactively identifies potential challenges, risks, and opportunities related to the data management function and strives to achieve best in class data management performance for all business units and regions.
• Perform implementation of data functions for new business.
• Participate in audits of internal files and external vendors.
• Management and oversight of data management personnel. Implement methods to support individual and team development.
• Perform other duties as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!

Education / Experience Requirements

• Bachelor’s degree in a technical or clinical field, or equivalent related work experience in the respective field
• Minimum of 4 years of relevant work experience to include data management of clinical studies
• Previous experience leading teams or managing direct reports required
• Proficiency using Veeva Vault, electronic data capture systems, Excel, and Access
• Expertise in case report form design and data validation using Electronic Data Capturing systems
• Experience working under US and international clinical regulations and guidance

Specialized Skills / Other Requirements

• Strong organizational, communication and documentation skills, proven ability to review and coordinate the collection of data and related documentation for research studies
• Ability to make independent decisions and take responsibility for own actions within a fast-moving environment.
• Understanding of business process improvement and the tools and data requirements for supporting an effective business process improvement practice
• Ability to collaborate effectively and participate in a team environment
• Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
• Excellent verbal and written communication skills, including presentation skills

The pay range for this position at commencement of employment is expected to be between $130,000 - $160,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.