Senior Manager, Clinical Data Management

Worldwide Salaried Open

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:

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