Job Description:

• Report into the Executive Director, Clinical Data Management.
• Focus on all aspects of the CDM process from project planning, development of project documentation, system set-up, UAT through database lock.
• Responsible for timelines and quality of CDM deliverables for the assigned studies.
• Contributes to technical infrastructure of CDM such as the development of SOPs, departmental process improvement etc.
• Provides feedback and task assignment to meet department and company objectives.
• Supports budget and resource planning across assigned projects as required.
• Participates in CRO/vendor selection process for outsourced activities.
• Directs activities of direct reports as applicable.
• Represents CDM in study team meetings.
• Manages CDM timelines to coordinate and synchronize deliverables with overall study timelines.
• 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).
• Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices).
• Monitors the progress of all CDM activities for the project to ensure project timelines are met.
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal.

Requirements:

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

Benefits:

• Annual performance incentive bonus
• New hire equity package
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) match
• Paid time off
• Paid holidays