Senior Manager, Data Management

Role Summary

Senior Manager, Data Management (Remote). You will focus on all aspects of the CDM process from project planning, the development of project documentation, system set-up, UAT through database lock. This person is a department-level contributor and may have oversight of junior CDM staff. The core duties and responsibilities are delineated below.

Responsibilities

• Department Level: Responsible for timelines and quality of CDM deliverables for the assigned studies.
• Department Level: Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
• Department Level: Provides feedback and task assignment to meet department and company objectives.
• Department Level: Supports budget and resource planning across assigned projects as required.
• Department Level: Participates in CRO/vendor selection process for outsourced activities.
• Department Level: Directs activities of direct reports as applicable.
• Department Level: Participates in department or cross-functional initiatives as appropriate.
• DM/Study Tasks: Represents CDM in study team meetings.
• DM/Study Tasks: Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines.
• DM/Study Tasks: Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions).
• DM/Study Tasks: Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices).
• DM/Study Tasks: Monitors the progress of all CDM activities for the project to ensure project timelines are met.
• DM/Study Tasks: Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal.
• DM/Study Tasks: Performs duties as assigned by CDM management/Head of Department.

Qualifications

• Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry.
• Three (3) year of staff management desired.
• Demonstrated ability to pay attention to details and superior organizational skills.
• CRO management experience.
• In-depth knowledge of CDM principles, clinical trial process and regulatory requirements.
• Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proven ability to work both independently and in a team setting.
• Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Prior oncology/hematology experience highly desirable.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.

Education

• Bachelor’s, or Master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field.